Breast CancerNCT04245657
Factors Affecting Functionality in Breast Cancer Survivors
An observational study of Breast Cancer and Breast Cancer Female, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most frequent cancer type in women globally. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, Breast Cancer Lymphedema
- What is being tested?
- Tissue Dielectric Constant Measurement, Muscle strength measurement and Hand-Grip Strength Measurement
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Dec 2019to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female Breast cancer survivors aged 25-65 years old who had unilateral breast cancer surgery will be enrolled to this study.
Who may be able to join
- Being aged between 25 and 65 years old
- Having the ability to read and write in the Turkish language
- Having unilateral (right or left) breast cancer surgery history
- Being a woman
- Finished adjuvant therapies such as chemotherapy and radiotherapy prior to participation
Who cannot join
- Active infection
- Active/recurrent malignity
- Having orthopedic and/or neurological defect
- Having an advanced postural deficiency
- Having nerve injury (Ulnar, median, radial nerve)
- Having a loss of sensory
Show all 11Show fewer
- Bilateral (both side) breast cancer surgery
- Having mental and cognitive problems which can interfere to participate
- Serious range of movement restriction in shoulder, elbow and/or wrist joints
- Having Carpal Tunnel Syndrome
- Having reflex denervation and abnormal neural findings
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Çiğli State Training Hospital
Izmir, Çiğli, 35620
About this study
Official title: Investigation of the Factors of Hang-Grip Strength-related Upper Extremity Functionality After Breast Cancer Surgery
Breast cancer is the most frequent cancer type in women globally. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. In addition, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program. There are studies that investigate upper extremity function associated with hang-grip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
Read the detailed description
Investigation of the Factors of Hand-Grip Strength-related Upper Extremity Functionality in Breast Cancer Survivors
Breast cancer is the most frequent cancer type in women globally. In the United States, there are almost 3 million breast cancer cases and this number gradually increasing in recent years. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. In addition to the reduced quality of life, breast cancer survivors experience reduced and altered upper extremity function. The Data not only reported by breast cancer survivors but also derived by objective assessment tools state that the high prevalence of disrupted upper extremity function. Studies reported that the deterioration of shoulder function and reduced strength and flexibility in the range of between 16% to 43%, however, these parameters followed a stabile pattern within a year while some parameters which are assessed relatively in short periods were found in higher prevalence. In addition to these, reduced mobility of head and neck, perceived fatigue, reduced upper extremity strength are factors that induce functional limitations in breast cancer survivors.
Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. Lymphedema is characterized by the inability of the function of the lymphatic system which can result in the accumulation of protein-rich lymphatic fluid in interstitial spaces in addition to skin changes in related body regions and extremities. Untreated lymphedema causes chronic inflammation, cellulitis, pain, fatigue, cosmetic deformity, restriction in mobility and related problems and therefore ineffective usage of the extremity concerning diminished functionality has occurred. It is known that the esthetical concern and emotional stress manifested by lymphedema cause deterioration in physical function. The heaviness feeling, fibrosis and skin infections caused by lymphedema not only can increase psychological stress but also induce musculoskeletal complications in the long term. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Through augmented severity and stage of lymphedema, reduced physical functions are taken place in the clinical condition. Patients without BCRL can increase their cumulative musculoskeletal problems by avoiding physical activity and exercise due to misguidance and fear of lymphedema while the ones with BCRL have to fear the increased severity of lymphedema by doing so. Lymphedema can bring with problems such as reduced physical activity and weight gain thereby constitution of the basis of functional limitations is settled.
Increased fat mass and body mass index are reported in the range of 50% to %96 in breast cancer survivors. Optimal upper extremity function is important for maintaining an independent daily life and day routines and to perform works that need physical strength in terms of the general quality of life. However, affecting factors and incidence of their impact on upper extremity function in the aspect of physical, functional and psychological are still have been the research issue. The literature reports that the frequently reduced muscle strength due to cancer-related symptoms along with the altered motor control in shoulder and neck musculature. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. Besides, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program.
Some studies investigate upper extremity function associated with handgrip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
The primary purpose of this study:
This study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
Secondary aim:
Which of the aforementioned parameters has the most prominent effect on hand-grip strength related upper extremity functionality in breast cancer survivors
Primary endpoint:
Having reached to a targeted number of breast cancer survivors compatible with the incl/excl criteria of this study
Secondary endpoint:
According to the pilot test result, elimination of parameters that are not significant in the statistical model will be excluded and power analysis will be re-performed. If the current number of the targeted population has been achieved (by achieving at least 80% power, 95% CI), then the study will be finished to save time and resources.
Center: Single-center study
Time range: December 2019- October 2020
Methods:
109 women aged between 25 and 65 years who had unilateral breast cancer surgery will be included in this study (Sample size was determined according to the 0.15 effect size, 80% power, and 95% confidence interval). Within the context of this study, an evaluation form that assesses demographic information (Both patient and clinical demographics such as Name, age, contact information and/or body mass index, time spent after surgery, surgery type, etc) will be requested to fill. Within this form, having lymphedema (yes/no), drug use (especially tamoxifen, yes/no), pain assessment (via visual analog scale), adjuvant therapies (radiotherapy, chemotherapy, yes/no, number of sessions, etc) and shoulder range of motion assessment via goniometer will be evaluated and recorded to the assessment form.
Tissue Dielectric Constant Measurement:
Sub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system.
Muscle strength Participants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded.
Hand-Grip Strength Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded.
Pain Threshold Measurement The sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (deltoid tuberosity), dorsum of the webspace. Measurements will te took both for right and left upper extremity. Units will be recorded as kgf.
Scales and Forms There will be scales and form which are required to fill out by participants. The following list of scales will be filled with participants themselves.
International Physical Activity Questionnaire-Short Form (IPAQ-SF):
This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded.
Fatigue Impact Scale:
This scale has 9 items that can be answered as "Strongly Disagree" through "Strongly Agree" by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less.
Disabilities of Arm, Shoulder and Hand Scale (DASH):
DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: "No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function.
Exercise Benefits/ Barriers Scale Exercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise.
Beck Depression Scale
Beck Depression Scale has 21 items each can be scored within 0 to 3. All items are related to the depressive mood of a participant. The higher the score of the Beck Depression Scale, the higher the depression level.
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Cancer Lymphedema, Breast Carcinoma in Situ, Hand Grasp, Pain, Shoulder
- Being tested
- Tissue Dielectric Constant Measurement, Muscle strength measurement, Hand-Grip Strength Measurement, Pain Threshold Measurement, International Physical Activity Questionnaire-Short Form (IPAQ-SF)
- Keywords
- Breast Cancer, Lymphedema, Upper Extremity Function, Hand Grip Strength
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema, Breast Carcinoma In Situ, Shoulder Pain, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Dielectric Constant MeasurementOther
Sub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system. This device mainly aims to assess the dielectric constant of tissues which is related to the amount of tissue water. In the case of pre-lymphedema or lymphedema, one can assess objectively regarding sub-tissue fluid changes via this device. Triplicate measurements will be taken for each reference point.
Muscle strength measurementOther
Participants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded.
Hand-Grip Strength MeasurementOther
Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed.
Pain Threshold MeasurementOther
The sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (crista deltoidea), dorsum of the webspace.
International Physical Activity Questionnaire-Short Form (IPAQ-SF)Other
This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded.
Fatigue Impact ScaleOther
This scale has 9 items that can be answered as "Strongly Disagree" through "Strongly Agree" by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less.
Disabilities of Arm, Shoulder and Hand Scale (DASH)Other
DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: "No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function.
Exercise Benefits/ Barriers ScaleOther
Exercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise.
Beck Depression ScaleOther
Beck Depression Scale has 21 items each can be scored within 0 to 3. All items are related to the depressive mood of a participant. The higher the score of the Beck Depression Scale, the higher the depression level.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivors | Female breast cancer survivors who underwent unilateral breast cancer surgery ( total or conservative) and completed their adjuvant therapies such as chemotherapy and radiotherapy prior to participation in this study. Receives: Other: Tissue Dielectric Constant Measurement; Other: Muscle strength measurement; Other: Hand-Grip Strength Measurement; Other: Pain Threshold Measurement; Other: International Physical Activity Questionnaire-Short Form (IPAQ-SF); Other: Fatigue Impact Scale; Other: Disabilities of Arm, Shoulder and Hand Scale (DASH); Other: Exercise Benefits/ Barriers Scale; Other: Beck Depression Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand-Grip Strength
Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed.
Measured: 15 minutes
Secondary outcomes (7)
Tissue Dielectric Constant Measurement:
Sub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system.
Measured: 30 minutes
Muscle strength
Participants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded. 1 minute resting period will be provided between the positions at which muscle strength is assessed.
Measured: 10 minutes
Pain Threshold Measurement
The sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (crista deltoidea), dorsum of the webspace. Measurements will te took both for right and left upper extremity. Units will be recorded as kgf.
Measured: 8 minutes
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded.
Measured: 3 minutes
Fatigue Impact Scale
This scale has 9 items that can be answered as "Strongly Disagree" through "Strongly Agree" by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less.
Measured: 3 minutes
Disabilities of Arm, Shoulder and Hand Scale (DASH)
DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: "No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function.
Measured: 10 minutes
Exercise Benefits/ Barriers Scale
Exercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start17 Dec 2019
- Primary completion26 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Tuğral, Izmir Bakircay University
- Investigators
- Yeşim Bakar, Professor, Study director, Bakırçay University, Fac. of Health Sci, Dept. of Physical Therapy and Rehabİlker Kızıloğlu, MD, Principal investigator, İzmir Çiğli State Training Hospital, Department of General SurgeryAlper Tuğral, PT, Principal investigator, Bakırçay University, Fac. of Health Sci, Dept. of Physical Therapy and Rehab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245657
- Sponsor's protocol ID
- BakircayU
- Status last verified
- Nov 2021
- First submitted
- 27 Jan 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Angelis R, Tavilla A, Verdecchia A, Scoppa S, Hachey M, Feuer EJ, Mariotto AB. Breast cancer survivors in the United States: geographic variability and time trends, 2005-2015. Cancer. 2009 May 1;115(9):1954-66. doi: 10.1002/cncr.24217.
PubMed 19248047Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
PubMed 22294757Satariano WA, Ragland DR, DeLorenze GN. Limitations in upper-body strength associated with breast cancer: a comparison of black and white women. J Clin Epidemiol. 1996 May;49(5):535-44. doi: 10.1016/0895-4356(95)00565-x.
PubMed 8636727Armer JM. The problem of post-breast cancer lymphedema: impact and measurement issues. Cancer Invest. 2005;23(1):76-83.
PubMed 15779870Smoot B, Wong J, Cooper B, Wanek L, Topp K, Byl N, Dodd M. Upper extremity impairments in women with or without lymphedema following breast cancer treatment. J Cancer Surviv. 2010 Jun;4(2):167-78. doi: 10.1007/s11764-010-0118-x. Epub 2010 Apr 7.
PubMed 20373044Lee D, Hwang JH, Chu I, Chang HJ, Shim YH, Kim JH. Analysis of factors related to arm weakness in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Aug;23(8):2297-304. doi: 10.1007/s00520-014-2584-6. Epub 2015 Jan 10.
PubMed 25576430Nesvold IL, Reinertsen KV, Fossa SD, Dahl AA. The relation between arm/shoulder problems and quality of life in breast cancer survivors: a cross-sectional and longitudinal study. J Cancer Surviv. 2011 Mar;5(1):62-72. doi: 10.1007/s11764-010-0156-4. Epub 2010 Oct 23.
PubMed 20972640Garabeli Cavalli Kluthcovsky AC, Urbanetz AA, de Carvalho DS, Pereira Maluf EM, Schlickmann Sylvestre GC, Bonatto Hatschbach SB. Fatigue after treatment in breast cancer survivors: prevalence, determinants and impact on health-related quality of life. Support Care Cancer. 2012 Aug;20(8):1901-9. doi: 10.1007/s00520-011-1293-7. Epub 2011 Oct 13.
PubMed 21994001Wilmoth MC, Coleman EA, Smith SC, Davis C. Fatigue, weight gain, and altered sexuality in patients with breast cancer: exploration of a symptom cluster. Oncol Nurs Forum. 2004 Nov 16;31(6):1069-75. doi: 10.1188/04.ONF.1069-1075.
PubMed 15547630Winters-Stone KM, Bennett JA, Nail L, Schwartz A. Strength, physical activity, and age predict fatigue in older breast cancer survivors. Oncol Nurs Forum. 2008 Sep;35(5):815-21. doi: 10.1188/08.ONF.815-821.
PubMed 18765328Cantarero-Villanueva I, Fernandez-Lao C, Fernandez-DE-Las-Penas C, Diaz-Rodriguez L, Sanchez-Cantalejo E, Arroyo-Morales M. Associations among musculoskeletal impairments, depression, body image and fatigue in breast cancer survivors within the first year after treatment. Eur J Cancer Care (Engl). 2011 Sep;20(5):632-9. doi: 10.1111/j.1365-2354.2011.01245.x. Epub 2011 Mar 17.
PubMed 21410803Galiano-Castillo N, Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, Menjon-Beltran S, Arroyo-Morales M. Altered pattern of cervical muscle activation during performance of a functional upper limb task in breast cancer survivors. Am J Phys Med Rehabil. 2011 May;90(5):349-55. doi: 10.1097/PHM.0b013e318214e406.
PubMed 21765253Vardar-Yagli N, Sener G, Saglam M, Calik-Kutukcu E, Arikan H, Inal-Ince D, Savci S, Altundag K, Kutluk T, Ozisik Y, Kaya EB. Associations among physical activity, comorbidity, functional capacity, peripheral muscle strength and depression in breast cancer survivors. Asian Pac J Cancer Prev. 2015;16(2):585-9. doi: 10.7314/apjcp.2015.16.2.585.
PubMed 25684491Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-las-Penas C, Del-Moral-Avila R, Menjon-Beltran S, Arroyo-Morales M. Widespread mechanical pain hypersensitivity as a sign of central sensitization after breast cancer surgery: comparison between mastectomy and lumpectomy. Pain Med. 2011 Jan;12(1):72-8. doi: 10.1111/j.1526-4637.2010.01027.x. Epub 2010 Dec 10.
PubMed 21143767Dibai-Filho AV, de Jesus Guirro RR, Koga Ferreira VT, Kelly de Oliveira A, Maria de Almeida A, de Oliveira Guirro EC. Analysis of chronic myofascial pain in the upper trapezius muscle of breast cancer survivors and women with neck pain. J Bodyw Mov Ther. 2018 Apr;22(2):237-241. doi: 10.1016/j.jbmt.2017.04.012. Epub 2017 Apr 28.
PubMed 29861213
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Factors of Hang-Grip Strength-related Upper Extremity Functionality After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04245657
- Acronym / sponsor ID
- BakircayU
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Cancer Lymphedema, Breast Carcinoma in Situ, Hand Grasp, Pain, Shoulder
- Keywords
- Breast Cancer, Lymphedema, Upper Extremity Function, Hand Grip Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 26 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most frequent cancer type in women globally. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. In addition, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program. There are studies that investigate upper extremity function associated with hang-grip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
Detailed description
Investigation of the Factors of Hand-Grip Strength-related Upper Extremity Functionality in Breast Cancer Survivors
Breast cancer is the most frequent cancer type in women globally. In the United States, there are almost 3 million breast cancer cases and this number gradually increasing in recent years. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. In addition to the reduced quality of life, breast cancer survivors experience reduced and altered upper extremity function. The Data not only reported by breast cancer survivors but also derived by objective assessment tools state that the high prevalence of disrupted upper extremity function. Studies reported that the deterioration of shoulder function and reduced strength and flexibility in the range of between 16% to 43%, however, these parameters followed a stabile pattern within a year while some parameters which are assessed relatively in short periods were found in higher prevalence. In addition to these, reduced mobility of head and neck, perceived fatigue, reduced upper extremity strength are factors that induce functional limitations in breast cancer survivors.
Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. Lymphedema is characterized by the inability of the function of the lymphatic system which can result in the accumulation of protein-rich lymphatic fluid in interstitial spaces in addition to skin changes in related body regions and extremities. Untreated lymphedema causes chronic inflammation, cellulitis, pain, fatigue, cosmetic deformity, restriction in mobility and related problems and therefore ineffective usage of the extremity concerning diminished functionality has occurred. It is known that the esthetical concern and emotional stress manifested by lymphedema cause deterioration in physical function. The heaviness feeling, fibrosis and skin infections caused by lymphedema not only can increase psychological stress but also induce musculoskeletal complications in the long term. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Through augmented severity and stage of lymphedema, reduced physical functions are taken place in the clinical condition. Patients without BCRL can increase their cumulative musculoskeletal problems by avoiding physical activity and exercise due to misguidance and fear of lymphedema while the ones with BCRL have to fear the increased severity of lymphedema by doing so. Lymphedema can bring with problems such as reduced physical activity and weight gain thereby constitution of the basis of functional limitations is settled.
Increased fat mass and body mass index are reported in the range of 50% to %96 in breast cancer survivors. Optimal upper extremity function is important for maintaining an independent daily life and day routines and to perform works that need physical strength in terms of the general quality of life. However, affecting factors and incidence of their impact on upper extremity function in the aspect of physical, functional and psychological are still have been the research issue. The literature reports that the frequently reduced muscle strength due to cancer-related symptoms along with the altered motor control in shoulder and neck musculature. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. Besides, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program.
Some studies investigate upper extremity function associated with handgrip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
The primary purpose of this study:
This study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
Secondary aim:
Which of the aforementioned parameters has the most prominent effect on hand-grip strength related upper extremity functionality in breast cancer survivors
Primary endpoint:
Having reached to a targeted number of breast cancer survivors compatible with the incl/excl criteria of this study
Secondary endpoint:
According to the pilot test result, elimination of parameters that are not significant in the statistical model will be excluded and power analysis will be re-performed. If the current number of the targeted population has been achieved (by achieving at least 80% power, 95% CI), then the study will be finished to save time and resources.
Center: Single-center study
Time range: December 2019- October 2020
Methods:
109 women aged between 25 and 65 years who had unilateral breast cancer surgery will be included in this study (Sample size was determined according to the 0.15 effect size, 80% power, and 95% confidence interval). Within the context of this study, an evaluation form that assesses demographic information (Both patient and clinical demographics such as Name, age, contact information and/or body mass index, time spent after surgery, surgery type, etc) will be requested to fill. Within this form, having lymphedema (yes/no), drug use (especially tamoxifen, yes/no), pain assessment (via visual analog scale), adjuvant therapies (radiotherapy, chemotherapy, yes/no, number of sessions, etc) and shoulder range of motion assessment via goniometer will be evaluated and recorded to the assessment form.
Tissue Dielectric Constant Measurement:
Sub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system.
Muscle strength Participants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded.
Hand-Grip Strength Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded.
Pain Threshold Measurement The sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (deltoid tuberosity), dorsum of the webspace. Measurements will te took both for right and left upper extremity. Units will be recorded as kgf.
Scales and Forms There will be scales and form which are required to fill out by participants. The following list of scales will be filled with participants themselves.
International Physical Activity Questionnaire-Short Form (IPAQ-SF):
This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded.
Fatigue Impact Scale:
This scale has 9 items that can be answered as "Strongly Disagree" through "Strongly Agree" by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less.
Disabilities of Arm, Shoulder and Hand Scale (DASH):
DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: "No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function.
Exercise Benefits/ Barriers Scale Exercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise.
Beck Depression Scale
Beck Depression Scale has 21 items each can be scored within 0 to 3. All items are related to the depressive mood of a participant. The higher the score of the Beck Depression Scale, the higher the depression level.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | – | Other: Tissue Dielectric Constant Measurement, Other: Muscle strength measurement, Other: Hand-Grip Strength Measurement, Other: Pain Threshold Measurement, Other: International Physical Activity Questionnaire-Short Form (IPAQ-SF), Other: Fatigue Impact Scale, Other: Disabilities of Arm, Shoulder and Hand Scale (DASH), Other: Exercise Benefits/ Barriers Scale, Other: Beck Depression ScaleFemale breast cancer survivors who underwent unilateral breast cancer surgery ( total or conservative) and completed their adjuvant therapies such as chemotherapy and radiotherapy prior to participation in this study. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female Breast cancer survivors aged 25-65 years old who had unilateral breast cancer surgery will be enrolled to this study.
Key inclusion criteria (5 listed)
- Being aged between 25 and 65 years old
- Having the ability to read and write in the Turkish language
- Having unilateral (right or left) breast cancer surgery history
- Being a woman
- Finished adjuvant therapies such as chemotherapy and radiotherapy prior to participation
Key exclusion criteria (11 listed)
- Active infection
- Active/recurrent malignity
- Having orthopedic and/or neurological defect
- Having an advanced postural deficiency
- Having nerve injury (Ulnar, median, radial nerve)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Dielectric Constant MeasurementSub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system. This device mainly aims to assess the dielectric constant of tissues which is related to the amount of tissue water. In the case of pre-lymphedema or lymphedema, one can assess objectively regarding sub-tissue fluid changes via this device. Triplicate measurements will be taken for each reference point. | Other | Breast Cancer Survivors |
| Muscle strength measurementParticipants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded. | Other | Breast Cancer Survivors |
| Hand-Grip Strength MeasurementHandgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed. | Other | Breast Cancer Survivors |
| Pain Threshold MeasurementThe sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (crista deltoidea), dorsum of the webspace. | Other | Breast Cancer Survivors |
| International Physical Activity Questionnaire-Short Form (IPAQ-SF)This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded. | Other | Breast Cancer Survivors |
| Fatigue Impact ScaleThis scale has 9 items that can be answered as "Strongly Disagree" through "Strongly Agree" by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less. | Other | Breast Cancer Survivors |
| Disabilities of Arm, Shoulder and Hand Scale (DASH)DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: "No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function. | Other | Breast Cancer Survivors |
| Exercise Benefits/ Barriers ScaleExercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise. | Other | Breast Cancer Survivors |
| Beck Depression ScaleBeck Depression Scale has 21 items each can be scored within 0 to 3. All items are related to the depressive mood of a participant. The higher the score of the Beck Depression Scale, the higher the depression level. | Other | Breast Cancer Survivors |
Primary outcome
Hand-Grip Strength
Time frame: 15 minutes
Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed.
7 secondary outcomes
Tissue Dielectric Constant Measurement:
Time frame: 30 minutes
Muscle strength
Time frame: 10 minutes
Pain Threshold Measurement
Time frame: 8 minutes
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: 3 minutes
Fatigue Impact Scale
Time frame: 3 minutes
Disabilities of Arm, Shoulder and Hand Scale (DASH)
Time frame: 10 minutes
Exercise Benefits/ Barriers Scale
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Background: PubMed 19248047De Angelis R, Tavilla A, Verdecchia A, Scoppa S, Hachey M, Feuer EJ, Mariotto AB. Breast cancer survivors in the United States: geographic variability and time trends, 2005-2015. Cancer. 2009 May 1;115(9):1954-66. doi: 10.1002/cncr.24217.
- Background: PubMed 22294757Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
- Background: PubMed 8636727Satariano WA, Ragland DR, DeLorenze GN. Limitations in upper-body strength associated with breast cancer: a comparison of black and white women. J Clin Epidemiol. 1996 May;49(5):535-44. doi: 10.1016/0895-4356(95)00565-x.
- Background: PubMed 15779870Armer JM. The problem of post-breast cancer lymphedema: impact and measurement issues. Cancer Invest. 2005;23(1):76-83.
- Background: PubMed 20373044Smoot B, Wong J, Cooper B, Wanek L, Topp K, Byl N, Dodd M. Upper extremity impairments in women with or without lymphedema following breast cancer treatment. J Cancer Surviv. 2010 Jun;4(2):167-78. doi: 10.1007/s11764-010-0118-x. Epub 2010 Apr 7.
- Background: PubMed 25576430Lee D, Hwang JH, Chu I, Chang HJ, Shim YH, Kim JH. Analysis of factors related to arm weakness in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Aug;23(8):2297-304. doi: 10.1007/s00520-014-2584-6. Epub 2015 Jan 10.
- Background: PubMed 20972640Nesvold IL, Reinertsen KV, Fossa SD, Dahl AA. The relation between arm/shoulder problems and quality of life in breast cancer survivors: a cross-sectional and longitudinal study. J Cancer Surviv. 2011 Mar;5(1):62-72. doi: 10.1007/s11764-010-0156-4. Epub 2010 Oct 23.
- Background: PubMed 21994001Garabeli Cavalli Kluthcovsky AC, Urbanetz AA, de Carvalho DS, Pereira Maluf EM, Schlickmann Sylvestre GC, Bonatto Hatschbach SB. Fatigue after treatment in breast cancer survivors: prevalence, determinants and impact on health-related quality of life. Support Care Cancer. 2012 Aug;20(8):1901-9. doi: 10.1007/s00520-011-1293-7. Epub 2011 Oct 13.
- Background: PubMed 15547630Wilmoth MC, Coleman EA, Smith SC, Davis C. Fatigue, weight gain, and altered sexuality in patients with breast cancer: exploration of a symptom cluster. Oncol Nurs Forum. 2004 Nov 16;31(6):1069-75. doi: 10.1188/04.ONF.1069-1075.
- Background: PubMed 18765328Winters-Stone KM, Bennett JA, Nail L, Schwartz A. Strength, physical activity, and age predict fatigue in older breast cancer survivors. Oncol Nurs Forum. 2008 Sep;35(5):815-21. doi: 10.1188/08.ONF.815-821.
- Background: PubMed 21410803Cantarero-Villanueva I, Fernandez-Lao C, Fernandez-DE-Las-Penas C, Diaz-Rodriguez L, Sanchez-Cantalejo E, Arroyo-Morales M. Associations among musculoskeletal impairments, depression, body image and fatigue in breast cancer survivors within the first year after treatment. Eur J Cancer Care (Engl). 2011 Sep;20(5):632-9. doi: 10.1111/j.1365-2354.2011.01245.x. Epub 2011 Mar 17.
- Background: PubMed 21765253Galiano-Castillo N, Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, Menjon-Beltran S, Arroyo-Morales M. Altered pattern of cervical muscle activation during performance of a functional upper limb task in breast cancer survivors. Am J Phys Med Rehabil. 2011 May;90(5):349-55. doi: 10.1097/PHM.0b013e318214e406.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeşim Bakar, Professor study director
Bakırçay University, Fac. of Health Sci, Dept. of Physical Therapy and Rehab
İlker Kızıloğlu, MD principal investigator
İzmir Çiğli State Training Hospital, Department of General Surgery
Alper Tuğral, PT principal investigator
Bakırçay University, Fac. of Health Sci, Dept. of Physical Therapy and Rehab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Cancer Female, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand-Grip Strength (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245657, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.