Head and Neck CancerNCT04286698
Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment
A study testing Complex decongestive physiotherapy and Home program in people with Head and Neck Cancer and Lymphedema of Face, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effects of complex decongestive physiotherapy (CDP) and home programs on internal/external lymphedema, staging, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema. Read more about this study
- Who is it for?
- Ages 22 to 73 years
- Conditions the study is for
- Head and Neck Cancer, Lymphedema of Face, Fibrosis; Skin
- What is being tested?
- Complex decongestive physiotherapy and Home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2018to 15 Mar 2019
- Phase
- Interventional
- 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 22 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- had unilateral/bilateral neck dissection
- had received radiotherapy and/or chemotherapy
- elapsed time of 3 or more months since cancer treatments
- had secondary HNL
Who cannot join
- having metastases due to HNC or other primary cancers
- receiving/having received treatment to regulate the lymph flow
- having the diagnosis of neurological, orthopedic, or rheumatologic diseases that may cause circulation and movement in the head and neck region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Effectiveness of Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment
The aim of this study was to determine the effects of complex decongestive physiotherapy (CDP) and home programs on internal/external lymphedema, staging, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema. Twenty-one patients were randomly divided into three groups: CDP; home program including self manual lymph drainage (MLD) and exercises; and control. CDP included MLD drainage, compression, exercise, and skin care. Self-MLD and exercises were performed by home program group patients. Assessment methods were applied at baseline and 4 weeks later for all groups. MD. Anderson Cancer Center Head and Neck Lymphedema Protocol was implemented to evaluate head and neck external lymphedema, staging, and fibrosis. An Artec Eva 3D scanner and the Autodesk ReCap Photo Studio software were used to determine and calculate the volume of the head and neck region via 3D surface scanning. Head and neck external lymphedema and fibrosis assessment criteria were performed to evaluate visible soft tissue edema and the degree of stiffness. To assess internal lymphedema, Patterson's scale was applied using fiber-optic endoscopic imaging.
Read the detailed description
Head and neck cancer (HNC) have been seen in 13.3/100,000 males and 2.8/100,000 in females in Turkey. HNC related treatments such as lymph node dissection, tumor excision, chemotherapy, radiotherapy, and cancer itself can cause head and neck lymphedema (HNL). The incidence of HNL due to HNC treatments (surgery, chemotherapy and chemoradiation) has been reported to be between 48% and 90%.
A recognition of HNL has been growing in recent years, but HNL is still much less recognized than upper and lower limb lymphedema and is easily ignored by both patients and health care providers. Therefore, in many cases, the diagnosis and treatment of HNL may be delayed, or patients cannot access treatment. In routine practice, after HNC, the self-absorption of HNL is generally expected. Clinical experiences have confirmed that HNL develops 2-6 months after cancer treatment and regresses in some patients over time.
A variety of physiotherapy approaches have been shown to prevent and minimize physical, functional, emotional, and social disorders resulting from HNL. However, complex decongestive physiotherapy (CDP) is considered a gold standard treatment method for lymphedema. This method consists of manual lymph drainage (MLD), skin care, compression therapy, and therapeutic exercises. Although there are many studies about the effects of CDP on upper and lower limbs, there is only a limited number of studies about HNL and CDP in the literature.
- Conditions
- Head and Neck Cancer, Lymphedema of Face, Fibrosis; Skin
- Being tested
- Complex decongestive physiotherapy, Home program
- Keywords
- Complex decongestive physiotherapy, Home program, Manual lymph drainage, Face mask, 3D analysis
- Medical subject headings
- Head and Neck Neoplasms, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex decongestive physiotherapyOther
MLD was administered 5 days a week for 4 weeks, with each session lasting 30 minutes [25]. Compression therapy was applied to the patients by wearing a compression mask (FM Velcro Fastener, LIPOELASTIC), made of polyamide, cotton, viscose, and elastane, that covered the submandibular region, the masseter region, and the neck. The compression mask is specifically designed for the healing and recovery of tissues after plastic and aesthetic surgeries. The patients were advised to wear the compression masks for at least 4-6 hours per day for 4 weeks and gradually increase wearing time according to their tolerance. The patients were asked to perform skin care by themselves. Skin care was applied using a low pH skin lotion to moisturize the skin. Neck, face/mimic, tongue, and posture exercises were performed by patients while the compression mask was worn and under the supervision of a physiotherapist, with 10 repetitions 5 times a week for 4 weeks.
Home programOther
Self-MLD and exercises (neck, face/mimic, tongue, and posture exercises) were shown to the patients in this group. Self-MLD included self-administered lymph drainage of the axillary, posterior, lateral, and anterior neck areas; the pre- and retro-auricular regions; the lateral and anterior regions of the face; and the lower jaw region. Then the order is reversed back to the starting point [3]. A video of self-MLD and a text including exercise descriptions were shared with patients and their relatives to ensure that the self-MLD and exercises were performed accurately and regularly at home. Self-MLD was recommended to be applied once a day, and the exercises were advised to be performed for 10 repetitions each, 10 times a day for 4 weeks. The patients were called by phone during the second week after their first evaluation as a control and to motivate the patient for performing self-MLD and home exercises properly.
| Study group | Role | What they receive |
|---|---|---|
| Complex decongestive physiotherapy program group | Active comparator | Manuel lymph drainage, compression mask, exercises and skin care Receives: Other: Complex decongestive physiotherapy |
| Home program group | Active comparator | Self-manuel lymph drainage and home exercises Receives: Other: Home program |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Internal Lymphedema at 4 weeks
Patterson's scale is the most comprehensive scale for evaluating internal HNL. It is a fiber-optic endoscopic imaging method applied by an otolaryngologist to assess the gaps in the pharynx and larynx with regard to edema. Also, 11 different structures (base of tongue, posterior pharyngeal wall, epiglottis, pharyngoepiglottic folds, aryepiglottic folds, interarytenoid space, cricopharyngeal prominence, arytenoids, false vocal folds, true vocal folds, anterior commissure) and two spaces (vallecula and pyriform sinus) are rated as normal, mild, moderate, or severe during the inspection [26].
Measured: At baseline and 4 weeks later
Change from Baseline External Lymphedema at 4 weeks
The MD Anderson Cancer Center HNL standard evaluation protocol includes two facial circumference measurements and nine point-to-point tape measurements between the reference points on the face [27].
Seven key facial measurements were totaled to form a composite facial score. In addition, composite neck score was obtained by performing circumference measurements from three different regions of the neck [27].
In order to clinically determine the development of external HNL, a reduction in the lymphedema stage or a minimum 2% reduction was required in absolute values in composite measurements that were equivalent to a change of at least 2 cm [2, 28].
Measured: At baseline and 4 weeks later
Change from Baseline Staging Lymphedema at 4 weeks
The MD Anderson Cancer Center HNL rating scale was based on the traditional Földi's scale, which is used for staging limb lymphedema and determining the severity [3]. The only difference between the MD Anderson Cancer Center HNL rating scale and Földi's scale is that Stage 1 is divided into Stage 1a and Stage 1b on Földi's scale. Stage 0 demonstrates lymphedema without visible edema but with a complaint of tissue heaviness. Stage 1a represents soft visible edema without pitting and which is reversible. Stage 1b shows soft pitting edema, which remains reversible. Stage 2 displays firm pitting edema, which is irreversible but lacks tissue changes. Stage 3 lymphedema, the most severe of all stages, represents irreversible tissue changes such as hyperkeratosis or papillomatosis [27].
Measured: At baseline and 4 weeks later
Change from Baseline Characteristics of Tissue Changes (edema and/or fibrosis), The Anatomical Locations, and The Severity of The Identified Soft Tissue Abnormalities at 4 weeks
The HNC related external lymphedema and fibrosis assessment criteria were used to evaluate the parameters, including the presence of visible soft tissue edema, the degree of stiffness of the tissues involved, and the severity of the lymphedema on the left periorbital region, right periorbital region, left cheek, right cheek, and submental region. This scale was used for rating the tissue under four headings for each region: Type A, Type B, Type C, and Type D. Next, each type other than Type A was graded as mild, moderate, and severe [29].
Measured: At baseline and 4 weeks later
Change from Baseline 3D Surface Scanning and Volume Evaluation at 4 weeks
This evaluation was applied with an Artec Eva 3D scanner. The measurements and analyses were performed for seven different anatomical reference points. Seven markers were used to facilitate the calculation of the volume of the face and neck following the 3D scanning of the face and neck area; the data obtained were transferred to computer. After the scan was completed, a pattern atlas was created using the Autodesk ReCap photo software for the data on image, geometry, and texture. Finally, the predetermined reference points were combined, and the volume of the remaining portion was calculated by the volume of the 3D network representing the scanned geometry. In addition, the properties of the object were calculated using MESHLAB software.
Measured: At baseline and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start5 Mar 2018
- Primary completion15 Feb 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286698
- Sponsor's protocol ID
- 2018-112
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith BG, Hutcheson KA, Little LG, Skoracki RJ, Rosenthal DI, Lai SY, Lewin JS. Lymphedema outcomes in patients with head and neck cancer. Otolaryngol Head Neck Surg. 2015 Feb;152(2):284-291. doi: 10.1177/0194599814558402. Epub 2014 Nov 11.
PubMed 25389318Deng J, Ridner SH, Dietrich MS, Wells N, Wallston KA, Sinard RJ, Cmelak AJ, Murphy BA. Prevalence of secondary lymphedema in patients with head and neck cancer. J Pain Symptom Manage. 2012 Feb;43(2):244-52. doi: 10.1016/j.jpainsymman.2011.03.019. Epub 2011 Jul 30.
PubMed 21802897Ridner SH. Pathophysiology of lymphedema. Semin Oncol Nurs. 2013 Feb;29(1):4-11. doi: 10.1016/j.soncn.2012.11.002.
PubMed 23375061Deng J, Ridner SH, Murphy BA. Lymphedema in patients with head and neck cancer. Oncol Nurs Forum. 2011 Jan;38(1):E1-E10. doi: 10.1188/11.ONF.E1-E10.
PubMed 21186146Della Justina, L.B. and M. Dias, Head and neck lymphedema: what is the physical therapy approach? A literature review. Fisioterapia em Movimento, 2016. 29(2): p. 411-419.
Smile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355.
PubMed 28009597Watanabe Y, Koshiyama M, Seki K, Nakagawa M, Ikuta E, Oowaki M, Sakamoto SI. Development and Themes of Diagnostic and Treatment Procedures for Secondary Leg Lymphedema in Patients with Gynecologic Cancers. Healthcare (Basel). 2019 Aug 27;7(3):101. doi: 10.3390/healthcare7030101.
PubMed 31461980Crane P, Feinberg L, Morris J. A multimodal physical therapy approach to the management of a patient with temporomandibular dysfunction and head and neck lymphedema: a case report. J Man Manip Ther. 2015 Feb;23(1):37-42. doi: 10.1179/2042618612Y.0000000021.
PubMed 26309380Piso DU, Eckardt A, Liebermann A, Gutenbrunner C, Schafer P, Gehrke A. Early rehabilitation of head-neck edema after curative surgery for orofacial tumors. Am J Phys Med Rehabil. 2001 Apr;80(4):261-9. doi: 10.1097/00002060-200104000-00006.
PubMed 11277132Doke KN, Bowman L, Shnayder Y, Shen X, TenNapel M, Thomas SM, Neupane P, Yeh HW, Lominska CE. Quantitative clinical outcomes of therapy for head and neck lymphedema. Adv Radiat Oncol. 2018 Apr 27;3(3):366-371. doi: 10.1016/j.adro.2018.04.007. eCollection 2018 Jul-Sep.
PubMed 30202804Ozdemir K, Keser I, Duzlu M, Erpolat OP, Saranli U, Tutar H. The Effects of Clinical and Home-based Physiotherapy Programs in Secondary Head and Neck Lymphedema. Laryngoscope. 2021 May;131(5):E1550-E1557. doi: 10.1002/lary.29205. Epub 2020 Oct 28.
PubMed 33111977
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effectiveness of Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment
- ClinicalTrials.gov ID
- NCT04286698
- Acronym / sponsor ID
- 2018-112
- Conditions
- Head and Neck Cancer, Lymphedema of Face, Fibrosis; Skin
- Keywords
- Complex decongestive physiotherapy, Home program, Manual lymph drainage, Face mask, 3D analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 27 Feb 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.
The aim of this study was to determine the effects of complex decongestive physiotherapy (CDP) and home programs on internal/external lymphedema, staging, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema. Twenty-one patients were randomly divided into three groups: CDP; home program including self manual lymph drainage (MLD) and exercises; and control. CDP included MLD drainage, compression, exercise, and skin care. Self-MLD and exercises were performed by home program group patients. Assessment methods were applied at baseline and 4 weeks later for all groups. MD. Anderson Cancer Center Head and Neck Lymphedema Protocol was implemented to evaluate head and neck external lymphedema, staging, and fibrosis. An Artec Eva 3D scanner and the Autodesk ReCap Photo Studio software were used to determine and calculate the volume of the head and neck region via 3D surface scanning. Head and neck external lymphedema and fibrosis assessment criteria were performed to evaluate visible soft tissue edema and the degree of stiffness. To assess internal lymphedema, Patterson's scale was applied using fiber-optic endoscopic imaging.
Detailed description
Head and neck cancer (HNC) have been seen in 13.3/100,000 males and 2.8/100,000 in females in Turkey. HNC related treatments such as lymph node dissection, tumor excision, chemotherapy, radiotherapy, and cancer itself can cause head and neck lymphedema (HNL). The incidence of HNL due to HNC treatments (surgery, chemotherapy and chemoradiation) has been reported to be between 48% and 90%.
A recognition of HNL has been growing in recent years, but HNL is still much less recognized than upper and lower limb lymphedema and is easily ignored by both patients and health care providers. Therefore, in many cases, the diagnosis and treatment of HNL may be delayed, or patients cannot access treatment. In routine practice, after HNC, the self-absorption of HNL is generally expected. Clinical experiences have confirmed that HNL develops 2-6 months after cancer treatment and regresses in some patients over time.
A variety of physiotherapy approaches have been shown to prevent and minimize physical, functional, emotional, and social disorders resulting from HNL. However, complex decongestive physiotherapy (CDP) is considered a gold standard treatment method for lymphedema. This method consists of manual lymph drainage (MLD), skin care, compression therapy, and therapeutic exercises. Although there are many studies about the effects of CDP on upper and lower limbs, there is only a limited number of studies about HNL and CDP in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Complex decongestive physiotherapy program group | Active comparator | Other: Complex decongestive physiotherapyManuel lymph drainage, compression mask, exercises and skin care |
| Home program group | Active comparator | Other: Home programSelf-manuel lymph drainage and home exercises |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 22 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years old
- had unilateral/bilateral neck dissection
- had received radiotherapy and/or chemotherapy
- elapsed time of 3 or more months since cancer treatments
- had secondary HNL
Key exclusion criteria (3 listed)
- having metastases due to HNC or other primary cancers
- receiving/having received treatment to regulate the lymph flow
- having the diagnosis of neurological, orthopedic, or rheumatologic diseases that may cause circulation and movement in the head and neck region.
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 |
|---|---|---|
| Complex decongestive physiotherapyMLD was administered 5 days a week for 4 weeks, with each session lasting 30 minutes [25]. Compression therapy was applied to the patients by wearing a compression mask (FM Velcro Fastener, LIPOELASTIC), made of polyamide, cotton, viscose, and elastane, that covered the submandibular region, the masseter region, and the neck. The compression mask is specifically designed for the healing and recovery of tissues after plastic and aesthetic surgeries. The patients were advised to wear the compression masks for at least 4-6 hours per day for 4 weeks and gradually increase wearing time according to their tolerance. The patients were asked to perform skin care by themselves. Skin care was applied using a low pH skin lotion to moisturize the skin. Neck, face/mimic, tongue, and posture exercises were performed by patients while the compression mask was worn and under the supervision of a physiotherapist, with 10 repetitions 5 times a week for 4 weeks. | Other | Complex decongestive physiotherapy program group |
| Home programSelf-MLD and exercises (neck, face/mimic, tongue, and posture exercises) were shown to the patients in this group. Self-MLD included self-administered lymph drainage of the axillary, posterior, lateral, and anterior neck areas; the pre- and retro-auricular regions; the lateral and anterior regions of the face; and the lower jaw region. Then the order is reversed back to the starting point [3]. A video of self-MLD and a text including exercise descriptions were shared with patients and their relatives to ensure that the self-MLD and exercises were performed accurately and regularly at home. Self-MLD was recommended to be applied once a day, and the exercises were advised to be performed for 10 repetitions each, 10 times a day for 4 weeks. The patients were called by phone during the second week after their first evaluation as a control and to motivate the patient for performing self-MLD and home exercises properly. | Other | Home program group |
Primary outcome
Change from Baseline Internal Lymphedema at 4 weeks
Time frame: At baseline and 4 weeks later
Patterson's scale is the most comprehensive scale for evaluating internal HNL. It is a fiber-optic endoscopic imaging method applied by an otolaryngologist to assess the gaps in the pharynx and larynx with regard to edema. Also, 11 different structures (base of tongue, posterior pharyngeal wall, epiglottis, pharyngoepiglottic folds, aryepiglottic folds, interarytenoid space, cricopharyngeal prominence, arytenoids, false vocal folds, true vocal folds, anterior commissure) and two spaces (vallecula and pyriform sinus) are rated as normal, mild, moderate, or severe during the inspection [26].
Change from Baseline External Lymphedema at 4 weeks
Time frame: At baseline and 4 weeks later
The MD Anderson Cancer Center HNL standard evaluation protocol includes two facial circumference measurements and nine point-to-point tape measurements between the reference points on the face [27]. Seven key facial measurements were totaled to form a composite facial score. In addition, composite neck score was obtained by performing circumference measurements from three different regions of the neck [27]. In order to clinically determine the development of external HNL, a reduction in the lymphedema stage or a minimum 2% reduction was required in absolute values in composite measurements that were equivalent to a change of at least 2 cm [2, 28].
Change from Baseline Staging Lymphedema at 4 weeks
Time frame: At baseline and 4 weeks later
The MD Anderson Cancer Center HNL rating scale was based on the traditional Földi's scale, which is used for staging limb lymphedema and determining the severity [3]. The only difference between the MD Anderson Cancer Center HNL rating scale and Földi's scale is that Stage 1 is divided into Stage 1a and Stage 1b on Földi's scale. Stage 0 demonstrates lymphedema without visible edema but with a complaint of tissue heaviness. Stage 1a represents soft visible edema without pitting and which is reversible. Stage 1b shows soft pitting edema, which remains reversible. Stage 2 displays firm pitting edema, which is irreversible but lacks tissue changes. Stage 3 lymphedema, the most severe of all stages, represents irreversible tissue changes such as hyperkeratosis or papillomatosis [27].
Change from Baseline Characteristics of Tissue Changes (edema and/or fibrosis), The Anatomical Locations, and The Severity of The Identified Soft Tissue Abnormalities at 4 weeks
Time frame: At baseline and 4 weeks later
The HNC related external lymphedema and fibrosis assessment criteria were used to evaluate the parameters, including the presence of visible soft tissue edema, the degree of stiffness of the tissues involved, and the severity of the lymphedema on the left periorbital region, right periorbital region, left cheek, right cheek, and submental region. This scale was used for rating the tissue under four headings for each region: Type A, Type B, Type C, and Type D. Next, each type other than Type A was graded as mild, moderate, and severe [29].
Change from Baseline 3D Surface Scanning and Volume Evaluation at 4 weeks
Time frame: At baseline and 4 weeks later
This evaluation was applied with an Artec Eva 3D scanner. The measurements and analyses were performed for seven different anatomical reference points. Seven markers were used to facilitate the calculation of the volume of the face and neck following the 3D scanning of the face and neck area; the data obtained were transferred to computer. After the scan was completed, a pattern atlas was created using the Autodesk ReCap photo software for the data on image, geometry, and texture. Finally, the predetermined reference points were combined, and the volume of the remaining portion was calculated by the volume of the 3D network representing the scanned geometry. In addition, the properties of the object were calculated using MESHLAB software.
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 27 Feb 2020.
- Background: PubMed 25389318Smith BG, Hutcheson KA, Little LG, Skoracki RJ, Rosenthal DI, Lai SY, Lewin JS. Lymphedema outcomes in patients with head and neck cancer. Otolaryngol Head Neck Surg. 2015 Feb;152(2):284-291. doi: 10.1177/0194599814558402. Epub 2014 Nov 11.
- Background: PubMed 21802897Deng J, Ridner SH, Dietrich MS, Wells N, Wallston KA, Sinard RJ, Cmelak AJ, Murphy BA. Prevalence of secondary lymphedema in patients with head and neck cancer. J Pain Symptom Manage. 2012 Feb;43(2):244-52. doi: 10.1016/j.jpainsymman.2011.03.019. Epub 2011 Jul 30.
- Background: PubMed 23375061Ridner SH. Pathophysiology of lymphedema. Semin Oncol Nurs. 2013 Feb;29(1):4-11. doi: 10.1016/j.soncn.2012.11.002.
- Background: PubMed 21186146Deng J, Ridner SH, Murphy BA. Lymphedema in patients with head and neck cancer. Oncol Nurs Forum. 2011 Jan;38(1):E1-E10. doi: 10.1188/11.ONF.E1-E10.
- BackgroundDella Justina, L.B. and M. Dias, Head and neck lymphedema: what is the physical therapy approach? A literature review. Fisioterapia em Movimento, 2016. 29(2): p. 411-419.
- Background: PubMed 28009597Smile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355.
- Background: PubMed 31461980Watanabe Y, Koshiyama M, Seki K, Nakagawa M, Ikuta E, Oowaki M, Sakamoto SI. Development and Themes of Diagnostic and Treatment Procedures for Secondary Leg Lymphedema in Patients with Gynecologic Cancers. Healthcare (Basel). 2019 Aug 27;7(3):101. doi: 10.3390/healthcare7030101.
- Background: PubMed 26309380Crane P, Feinberg L, Morris J. A multimodal physical therapy approach to the management of a patient with temporomandibular dysfunction and head and neck lymphedema: a case report. J Man Manip Ther. 2015 Feb;23(1):37-42. doi: 10.1179/2042618612Y.0000000021.
- Background: PubMed 11277132Piso DU, Eckardt A, Liebermann A, Gutenbrunner C, Schafer P, Gehrke A. Early rehabilitation of head-neck edema after curative surgery for orofacial tumors. Am J Phys Med Rehabil. 2001 Apr;80(4):261-9. doi: 10.1097/00002060-200104000-00006.
- Background: PubMed 30202804Doke KN, Bowman L, Shnayder Y, Shen X, TenNapel M, Thomas SM, Neupane P, Yeh HW, Lominska CE. Quantitative clinical outcomes of therapy for head and neck lymphedema. Adv Radiat Oncol. 2018 Apr 27;3(3):366-371. doi: 10.1016/j.adro.2018.04.007. eCollection 2018 Jul-Sep.
- Derived from this study: PubMed 33111977Ozdemir K, Keser I, Duzlu M, Erpolat OP, Saranli U, Tutar H. The Effects of Clinical and Home-based Physiotherapy Programs in Secondary Head and Neck Lymphedema. Laryngoscope. 2021 May;131(5):E1550-E1557. doi: 10.1002/lary.29205. Epub 2020 Oct 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex decongestive physiotherapy and Home program in people with Head and Neck Cancer and Lymphedema of Face, 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 3 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 27 Feb 2020. 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?
Change from Baseline Internal Lymphedema at 4 weeks (time frame: At baseline and 4 weeks later). 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 NCT04286698, which also lists 11 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 27 Feb 2020.