Breast Cancer Related LymphedemaNCT05776433
The Effects of Upper Extremity Lymphedema on Posture, Upper Extremity Functions, and Quality of Life
An observational study of Breast Cancer Related Lymphedema and Breast Cancer-Related Arm Lymphedema, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Related Lymphedema, Breast Cancer-Related Arm Lymphedema
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2022to 31 Oct 2022
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The sample of the study consists of patients who applied to Istanbul Dr Nazif Bağrıaçık Kadıköy Hospital in Istanbul between May 2022 and October 2022 and were diagnosed with upper extremity lymphedema after unilateral breast cancer by the doctor.
Who may be able to join
- Volunteering to participate in the research
- Be between the ages of 18-50
- Having had unilateral breast cancer
- At least one year since breast cancer treatment
- No active metastases
Who cannot join
- Arthritis
- Fibromyalgia syndrome
- Neurological diseases
- Mental illnesses
- Myopathic diseases
- Bilateral upper extremity lymphedema
Show all 10Show fewer
- Inability to communicate and cooperate
- Presence of any orthopaedic disease in the affected upper extremity
- Having scoliosis
- Having cognitive problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Nazif Bağrıaçık Kadıköy Hospital
Kadıköy, Istanbul, 34734
About this study
Official title: The Effects of Extremity With Lymphedema on Posture, Upper Extremity Functions, and Quality of Life in Patients With Lymphedema After Unilateral Breast Cancer
This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).
Read the detailed description
This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).
The hypotheses of our study:
Hypothesis 0 (H0):
There is no relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.
Hypothesis 1 (H1):
There is a relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral upper extremity lymphedema women after breast cancer treatment | The study group consisted of women aged 18-50 years with unilateral upper extremity lymphedema after breast cancer treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand (DASH)
It is a disability/symptom scoring system based on a self-report system of 30 items developed to evaluate upper extremity-specific physical functions and symptoms. The DASH questionnaire, which consists of three parts, contains 30 questions. Of these, 21 questions evaluate the patient's difficulty during physical activity, five assess symptoms (pain, activity-related pain, tingling, weakness, difficulty in movement), and the remaining four evaluate the patient's social function, work, sleep, and self-confidence. Questions are scored from 1 to 5 (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: none at all). The total score is between 0-100. The DASH score is calculated using the formula [sum of answers/n-1] x 25 (n=number of questions answered).
Measured: 10 minutes
Lymphedema Functionality, Disability, and Health Questionnaire (Lymph-ICF)
Lymph-ICF, a descriptive and evaluation tool, consists of 29 questions about the functional impairments, activity limitations, and participation restrictions reported by patients with breast cancer-related lymphedema. Physical function, mental function, home activities, mobility activities, and life and social activities are the five main components into which the questionnaire is subdivided. There is a visual analogue scale next to each question, and the patient marks the answer that suits themself. While calculating the survey score, the score of each subsection is found by summing and dividing by the number of questions answered. The total score is obtained by adding the scores of the subsections. A high score indicates that the effect on the quality of life is high.
Measured: 10 minutes
Upper Extremity Lymphedema-27 (ULL-27)
ULL-27 is a quality-of-life questionnaire evaluating upper extremity lymphedema as three components. The scale deals with physical, psychological and social components and consists of 27 questions. A 5-point Likert score (1=strongly disagree, 5=strongly agree) is used in the scale. The first 15 questions evaluate the physical component, questions between 16-22 evaluate the psychological component, and questions between 23-27 evaluate the social component. The lowest score is 27, and the highest score is 135. A high score on the scale indicates that lymphedema negatively affects the quality of life. The physical score consists of a total of fifteen questions, and this score of the person is between min 15 and 75. The psychological score consists of seven questions, with a minimum of 7 and a maximum of 35 points. There are five questions for the social score, with a minimum of 5 and a maximum of 25 points.
Measured: 10 minutes
Quality of Life Measure for Limb Lymphedema-Arm (LYMQOL-Arm)
The LYMQOL-Arm, primarily as a self-assessment report questionnaire assessing the symptoms of lymphedema in the upper extremity and the ability to perform functional activities in patients with breast cancer-associated lymphedema. There are five subsections in the 21-question survey. These are upper extremity function (questions 1a-h,2,3), appearance (questions 4-8), symptoms (questions 9-14), emotional state (questions 15-20), and general quality of life ( 21st question). In the first 20 questions, there are four options for each question: none (1 point), a little (2 points), quite (3 points), and a lot (4 points). The scores of these subsections are summed up within themselves and divided by the number of questions answered. In the 21st question, the patient is asked to give a value between 0 and 10 for the quality of life. High scores for the first 20 questions and low scores for the 21st question indicate poor quality of life.
Measured: 10 minutes
The New York Posture Analysis (NYPA)
Posture is the optimal form of all body parts about the whole body and the adjacent segment. This assessment test evaluates posture disorders that occur in 13 different body regions. The scoring of the test is as follows; A score of 5 is given if the person has a proper posture, 3 points if there is a moderate impairment, and 1 point if there is a severe disorder. The maximum score obtained at the end of the test is 65, and the minimum is 13. The standard evaluation criteria developed for the test are as follows for the total score; >=45: very good, 40-44: good, 30-39: medium, 20-29: weak, <=19:bad
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start2 May 2022
- Primary completion2 May 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Related LymphedemaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simla Turan, Yeditepe University
- Investigators
- Simla Turan, Principal investigator, Yeditepe UniversityFeryal Subaşı, Study director, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776433
- Sponsor's protocol ID
- YU-FTR-ST-01
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
PubMed 23540561Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.
PubMed 19001331Taghian NR, Miller CL, Jammallo LS, O'Toole J, Skolny MN. Lymphedema following breast cancer treatment and impact on quality of life: a review. Crit Rev Oncol Hematol. 2014 Dec;92(3):227-34. doi: 10.1016/j.critrevonc.2014.06.004. Epub 2014 Jul 2.
PubMed 25085806Haddad CA, Saad M, Perez Mdel C, Miranda Junior F. Assessment of posture and joint movements of the upper limbs of patients after mastectomy and lymphadenectomy. Einstein (Sao Paulo). 2013 Dec;11(4):426-34. doi: 10.1590/s1679-45082013000400004.
PubMed 24488379Leray H, Malloizel-Delaunay J, Lusque A, Chantalat E, Bouglon L, Chollet C, Chaput B, Garmy-Susini B, Yannoutsos A, Vaysse C. Body Mass Index as a Major Risk Factor for Severe Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2020 Dec;18(6):510-516. doi: 10.1089/lrb.2019.0009. Epub 2020 Apr 13.
PubMed 32283042Ridner SH, Dietrich MS, Stewart BR, Armer JM. Body mass index and breast cancer treatment-related lymphedema. Support Care Cancer. 2011 Jun;19(6):853-7. doi: 10.1007/s00520-011-1089-9. Epub 2011 Jan 16.
PubMed 21240649Belmonte R, Messaggi-Sartor M, Ferrer M, Pont A, Escalada F. Prospective study of shoulder strength, shoulder range of motion, and lymphedema in breast cancer patients from pre-surgery to 5 years after ALND or SLNB. Support Care Cancer. 2018 Sep;26(9):3277-3287. doi: 10.1007/s00520-018-4186-1. Epub 2018 Apr 12.
PubMed 29651594Levangie PK, Drouin J. Magnitude of late effects of breast cancer treatments on shoulder function: a systematic review. Breast Cancer Res Treat. 2009 Jul;116(1):1-15. doi: 10.1007/s10549-008-0246-4. Epub 2008 Nov 25.
PubMed 19031114Babasaheb SS, Rajesh KK, Yeshwant KS, Patil S. Analysis of Spinal Dysfunction in Breast Cancer Survivors with Lymphedema. Asian Pac J Cancer Prev. 2021 Jun 1;22(6):1869-1873. doi: 10.31557/APJCP.2021.22.6.1869.
PubMed 34181345Dawes DJ, Meterissian S, Goldberg M, Mayo NE. Impact of lymphoedema on arm function and health-related quality of life in women following breast cancer surgery. J Rehabil Med. 2008 Aug;40(8):651-8. doi: 10.2340/16501977-0232.
PubMed 19020699Park JE, Jang HJ, Seo KS. Quality of life, upper extremity function and the effect of lymphedema treatment in breast cancer related lymphedema patients. Ann Rehabil Med. 2012 Apr;36(2):240-7. doi: 10.5535/arm.2012.36.2.240. Epub 2012 Apr 30.
PubMed 22639749Pusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I, Hernandez M, Massey M, Cordeiro P, Morrow M, Mehrara B. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013 Mar;7(1):83-92. doi: 10.1007/s11764-012-0247-5. Epub 2012 Dec 5.
PubMed 23212603Rietman JS, Dijkstra PU, Hoekstra HJ, Eisma WH, Szabo BG, Groothoff JW, Geertzen JH. Late morbidity after treatment of breast cancer in relation to daily activities and quality of life: a systematic review. Eur J Surg Oncol. 2003 Apr;29(3):229-38. doi: 10.1053/ejso.2002.1403.
PubMed 12657232Ridner SH, Bonner CM, Deng J, Sinclair VG. Voices from the shadows: living with lymphedema. Cancer Nurs. 2012 Jan-Feb;35(1):E18-26. doi: 10.1097/NCC.0b013e31821404c0.
PubMed 21558848
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extremity With Lymphedema on Posture, Upper Extremity Functions, and Quality of Life in Patients With Lymphedema After Unilateral Breast Cancer
- ClinicalTrials.gov ID
- NCT05776433
- Acronym / sponsor ID
- YU-FTR-ST-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 20 Mar 2023 (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.
This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).
Detailed description
This study aims to examine the effects of lymphedema extremity on upper extremity function, posture and quality of life in patients who develop upper extremity lymphedema after unilateral breast cancer. Twenty-seven volunteers (27Female) diagnosed with upper extremity lymphedema after unilateral breast cancer treatment by a specialist physician between May 2022 and October 2022 were included in the study. Upper extremity circumference measurements of the individuals were performed on the healthy and affected sides. A goniometer measured both sides' upper extremity range of motion (ROM). The New York Posture Analysis (NYPA) was used for posture evaluation. Upper extremity functions were assessed by the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire and the Lymphedema Functionality, Disability and Health Questionnaire (Lymph-ICF). Quality of life was assessed by Upper Extremity Lymphedema-27 (ULL-27) and Quality of Life Measure for Limb Lymphedema -Arm (LYMQOL- Arm).
The hypotheses of our study:
Hypothesis 0 (H0):
There is no relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.
Hypothesis 1 (H1):
There is a relationship between upper extremity function, posture and quality of life in patients with upper extremity lymphedema after unilateral breast cancer treatment.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral upper extremity lymphedema women after breast cancer treatment | – | –The study group consisted of women aged 18-50 years with unilateral upper extremity lymphedema after breast cancer treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample of the study consists of patients who applied to Istanbul Dr Nazif Bağrıaçık Kadıköy Hospital in Istanbul between May 2022 and October 2022 and were diagnosed with upper extremity lymphedema after unilateral breast cancer by the doctor.
Key inclusion criteria (5 listed)
- Volunteering to participate in the research
- Be between the ages of 18-50
- Having had unilateral breast cancer
- At least one year since breast cancer treatment
- No active metastases
Key exclusion criteria (10 listed)
- Arthritis
- Fibromyalgia syndrome
- Neurological diseases
- Mental illnesses
- Myopathic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: 10 minutes
It is a disability/symptom scoring system based on a self-report system of 30 items developed to evaluate upper extremity-specific physical functions and symptoms. The DASH questionnaire, which consists of three parts, contains 30 questions. Of these, 21 questions evaluate the patient's difficulty during physical activity, five assess symptoms (pain, activity-related pain, tingling, weakness, difficulty in movement), and the remaining four evaluate the patient's social function, work, sleep, and self-confidence. Questions are scored from 1 to 5 (1: no difficulty, 2: mild difficulty, 3: medium difficulty, 4: extreme difficulty, 5: none at all). The total score is between 0-100. The DASH score is calculated using the formula [sum of answers/n-1] x 25 (n=number of questions answered).
Lymphedema Functionality, Disability, and Health Questionnaire (Lymph-ICF)
Time frame: 10 minutes
Lymph-ICF, a descriptive and evaluation tool, consists of 29 questions about the functional impairments, activity limitations, and participation restrictions reported by patients with breast cancer-related lymphedema. Physical function, mental function, home activities, mobility activities, and life and social activities are the five main components into which the questionnaire is subdivided. There is a visual analogue scale next to each question, and the patient marks the answer that suits themself. While calculating the survey score, the score of each subsection is found by summing and dividing by the number of questions answered. The total score is obtained by adding the scores of the subsections. A high score indicates that the effect on the quality of life is high.
Upper Extremity Lymphedema-27 (ULL-27)
Time frame: 10 minutes
ULL-27 is a quality-of-life questionnaire evaluating upper extremity lymphedema as three components. The scale deals with physical, psychological and social components and consists of 27 questions. A 5-point Likert score (1=strongly disagree, 5=strongly agree) is used in the scale. The first 15 questions evaluate the physical component, questions between 16-22 evaluate the psychological component, and questions between 23-27 evaluate the social component. The lowest score is 27, and the highest score is 135. A high score on the scale indicates that lymphedema negatively affects the quality of life. The physical score consists of a total of fifteen questions, and this score of the person is between min 15 and 75. The psychological score consists of seven questions, with a minimum of 7 and a maximum of 35 points. There are five questions for the social score, with a minimum of 5 and a maximum of 25 points.
Quality of Life Measure for Limb Lymphedema-Arm (LYMQOL-Arm)
Time frame: 10 minutes
The LYMQOL-Arm, primarily as a self-assessment report questionnaire assessing the symptoms of lymphedema in the upper extremity and the ability to perform functional activities in patients with breast cancer-associated lymphedema. There are five subsections in the 21-question survey. These are upper extremity function (questions 1a-h,2,3), appearance (questions 4-8), symptoms (questions 9-14), emotional state (questions 15-20), and general quality of life ( 21st question). In the first 20 questions, there are four options for each question: none (1 point), a little (2 points), quite (3 points), and a lot (4 points). The scores of these subsections are summed up within themselves and divided by the number of questions answered. In the 21st question, the patient is asked to give a value between 0 and 10 for the quality of life. High scores for the first 20 questions and low scores for the 21st question indicate poor quality of life.
The New York Posture Analysis (NYPA)
Time frame: 5 minutes
Posture is the optimal form of all body parts about the whole body and the adjacent segment. This assessment test evaluates posture disorders that occur in 13 different body regions. The scoring of the test is as follows; A score of 5 is given if the person has a proper posture, 3 points if there is a moderate impairment, and 1 point if there is a severe disorder. The maximum score obtained at the end of the test is 65, and the minimum is 13. The standard evaluation criteria developed for the test are as follows for the total score; >=45: very good, 40-44: good, 30-39: medium, 20-29: weak, <=19:bad
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 20 Mar 2023.
- Results publication: PubMed 23540561DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
- Results publication: PubMed 19001331Ahmed RL, Prizment A, Lazovich D, Schmitz KH, Folsom AR. Lymphedema and quality of life in breast cancer survivors: the Iowa Women's Health Study. J Clin Oncol. 2008 Dec 10;26(35):5689-96. doi: 10.1200/JCO.2008.16.4731. Epub 2008 Nov 10.
- Results publication: PubMed 25085806Taghian NR, Miller CL, Jammallo LS, O'Toole J, Skolny MN. Lymphedema following breast cancer treatment and impact on quality of life: a review. Crit Rev Oncol Hematol. 2014 Dec;92(3):227-34. doi: 10.1016/j.critrevonc.2014.06.004. Epub 2014 Jul 2.
- Results publication: PubMed 24488379Haddad CA, Saad M, Perez Mdel C, Miranda Junior F. Assessment of posture and joint movements of the upper limbs of patients after mastectomy and lymphadenectomy. Einstein (Sao Paulo). 2013 Dec;11(4):426-34. doi: 10.1590/s1679-45082013000400004.
- Results publication: PubMed 32283042Leray H, Malloizel-Delaunay J, Lusque A, Chantalat E, Bouglon L, Chollet C, Chaput B, Garmy-Susini B, Yannoutsos A, Vaysse C. Body Mass Index as a Major Risk Factor for Severe Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2020 Dec;18(6):510-516. doi: 10.1089/lrb.2019.0009. Epub 2020 Apr 13.
- Results publication: PubMed 21240649Ridner SH, Dietrich MS, Stewart BR, Armer JM. Body mass index and breast cancer treatment-related lymphedema. Support Care Cancer. 2011 Jun;19(6):853-7. doi: 10.1007/s00520-011-1089-9. Epub 2011 Jan 16.
- Results publication: PubMed 29651594Belmonte R, Messaggi-Sartor M, Ferrer M, Pont A, Escalada F. Prospective study of shoulder strength, shoulder range of motion, and lymphedema in breast cancer patients from pre-surgery to 5 years after ALND or SLNB. Support Care Cancer. 2018 Sep;26(9):3277-3287. doi: 10.1007/s00520-018-4186-1. Epub 2018 Apr 12.
- Results publication: PubMed 19031114Levangie PK, Drouin J. Magnitude of late effects of breast cancer treatments on shoulder function: a systematic review. Breast Cancer Res Treat. 2009 Jul;116(1):1-15. doi: 10.1007/s10549-008-0246-4. Epub 2008 Nov 25.
- Results publication: PubMed 34181345Babasaheb SS, Rajesh KK, Yeshwant KS, Patil S. Analysis of Spinal Dysfunction in Breast Cancer Survivors with Lymphedema. Asian Pac J Cancer Prev. 2021 Jun 1;22(6):1869-1873. doi: 10.31557/APJCP.2021.22.6.1869.
- Results publication: PubMed 19020699Dawes DJ, Meterissian S, Goldberg M, Mayo NE. Impact of lymphoedema on arm function and health-related quality of life in women following breast cancer surgery. J Rehabil Med. 2008 Aug;40(8):651-8. doi: 10.2340/16501977-0232.
- Results publication: PubMed 22639749Park JE, Jang HJ, Seo KS. Quality of life, upper extremity function and the effect of lymphedema treatment in breast cancer related lymphedema patients. Ann Rehabil Med. 2012 Apr;36(2):240-7. doi: 10.5535/arm.2012.36.2.240. Epub 2012 Apr 30.
- Results publication: PubMed 23212603Pusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I, Hernandez M, Massey M, Cordeiro P, Morrow M, Mehrara B. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013 Mar;7(1):83-92. doi: 10.1007/s11764-012-0247-5. Epub 2012 Dec 5.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Related Lymphedema
Recruiting
EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA
Breast Cancer Related Lymphedema
Active, not recruiting
Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema
Breast Cancer-Related Lymphedema, Lymphedema
Not yet recruiting
Early Intervention
Breast Cancer, Breast Cancer Treatment Related Lymphedema
Active, not recruiting
Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy
Breast Cancer Related Lymphedema
Not yet recruiting
Effects of Core-Focused Exercise Training and Kinesiology Taping in Women With Breast Cancer-Related Lymphedema
Breast Cancer Related Lymphedema
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.
Simla Turan principal investigator
Yeditepe University
Feryal Subaşı study director
Yeditepe University
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 Related Lymphedema and Breast Cancer-Related Arm Lymphedema, run by Yeditepe 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 10 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 20 Mar 2023. 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?
Disabilities of the Arm, Shoulder, and Hand (DASH) (time frame: 10 minutes). The study lists 5 primary outcomes in all. 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 NCT05776433, which also lists 14 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 20 Mar 2023; AzTrials last refreshed its copy on 26 Oct 2026.