Breast Cancer-Related LymphedemaNCT07794904
Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema
A study testing Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program and Home-Based Exercise and Self-Lymphatic Drainage Program in people with Breast Cancer-Related Lymphedema and Lymphedema, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
A total of 64 women, aged between 20 and 65 years, diagnosed with stage I or II breast cancer-related lymphedema and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Medical Faculty, will be included in… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer-Related Lymphedema, Lymphedema
- What is being tested?
- Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program and Home-Based Exercise and Self-Lymphatic Drainage Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants between 20 and 65 years of age
- History of unilateral breast cancer surgery including axillary lymph node dissection
- Completion of breast cancer treatments, including surgery, radiotherapy, and chemotherapy, with at least 3 months elapsed since treatment completion
- Diagnosis of stage I or stage II upper extremity lymphedema according to the International Society of Lymphology (ISL) classification
- Presence of at least 5% volume difference between the affected and unaffected upper extremities
- No history of manual lymphatic drainage, compression bandaging treatment, or structured resistance exercise program within the previous 3 months
- Ability to use a smartphone or tablet and sufficient cognitive and motor ability to participate in digital sessions
- Prescription of an appropriate compression garment for the affected extremity and regular use of the garment as recommended
Who cannot join
- Presence of uncontrolled hypertension, pulmonary edema, or severe cardiovascular disease
- Presence of psychiatric or cognitive impairment that may interfere with study participation or adherence
- Presence of stage III lymphedema according to the ISL classification
- Presence of skin lesions such as papilloma or hyperkeratosis in the lymphedematous area
- History of bilateral breast cancer
- Presence of active cancer or clinical/radiological evidence of metastasis
- Presence of active infection in the affected extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34093
About this study
Official title: Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema: A Single-Blind Randomized Controlled Trial
A total of 64 women, aged between 20 and 65 years, diagnosed with stage I or II breast cancer-related lymphedema and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Medical Faculty, will be included in our thesis study, which is planned to be prospective, randomized, and single-blind. Participants will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and written informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Participant assessment and follow-up forms will be completed before and after treatment. Participants who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention group or the control group by a computer program.
All participants will receive a face-to-face education session about breast cancer-related lymphedema, including exercise, self-lymphatic drainage, skin care, compression garment use, and self-management, together with an educational brochure. Participants in both groups will be asked to continue wearing their prescribed compression garments throughout the study. In addition to this education, the intervention group (G1) will join live Zoom sessions with the study physician three times a week for 8 weeks to perform the exercise and self-lymphatic drainage program under real-time supervision. Each session will include approximately 30 minutes of therapeutic exercises followed by 15 minutes of self-lymphatic drainage.
The control group (G2) will receive the same exercise and self-lymphatic drainage program in brochure format, including written instructions and illustrations. Participants will be asked to perform the exercise and self-lymphatic drainage program at home three times a week for 8 weeks without live online supervision.
- Conditions
- Breast Cancer-Related Lymphedema, Lymphedema
- Being tested
- Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program, Home-Based Exercise and Self-Lymphatic Drainage Program
- Keywords
- Breast Cancer-Related Lymphedema, Lymphedema, Tele-rehabilitation, Exercise, Self-Lymphatic Drainage, Self-Management
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage ProgramOther
The exercise and self-lymphatic drainage program will be performed under live online supervision.
Home-Based Exercise and Self-Lymphatic Drainage ProgramOther
The same exercise and self-lymphatic drainage program will be performed at home using an educational brochure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In addition to a face-to-face education session and educational brochure, participants will receive the exercise and self-lymphatic drainage program through live Zoom sessions with the study physician three times a week for 8 weeks. Receives: Other: Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program |
| Control Group | Active comparator | Face-to-face education session and educational brochure with the same exercise and self-lymphatic drainage program performed as a home-based program three times a week for 8 weeks. Receives: Other: Home-Based Exercise and Self-Lymphatic Drainage Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Affected Upper Extremity Volume
Limb volume is an objective measure used to evaluate swelling associated with upper extremity lymphedema. Bilateral arm circumference measurements will be obtained using a low-stretch measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle. Bilateral upper limb volume will be calculated indirectly using the truncated cone formula. The change from baseline in affected upper extremity volume will be evaluated as the primary outcome. Treatment response will additionally be assessed using the excess volume difference between the affected and unaffected limbs and the percentage change in excess volume (PCEV). Lymphedema severity will also be classified according to the excess limb volume difference as minimal (5-<20% increase), moderate (20-40% increase), and severe (>40% increase).
Measured: Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention)
Secondary outcomes (8)
Lymphedema Stage
Lymphedema stage will be assessed according to the International Society of Lymphology (ISL) classification system. The ISL classification categorizes lymphedema severity into stages 0, I, II, and III based on clinical findings. Stage 0 represents a latent or subclinical condition without evident swelling despite impaired lymphatic transport. Stage I is characterized by early fluid accumulation that decreases with limb elevation and may include pitting edema. Stage II involves persistent swelling with tissue changes, including fibrosis and fat deposition, with limited response to elevation. Stage III represents advanced lymphedema with marked swelling, fibrosis, fat deposition, and skin changes.
Measured: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Visual Analog Scale (VAS) for Lymphedema Symptom Severity
The Visual Analog Scale (VAS) is a commonly used assessment tool for measuring symptom intensity. Lymphedema symptom severity will be assessed using the VAS, a simple and reproducible tool used to evaluate the intensity of subjective symptoms. Participants will rate the severity of lymphedema-related symptoms, including fullness/tightness, heaviness, swelling, and pain in the affected extremity, on a 10-cm horizontal scale. The scale ranges from 0 (no symptom) to 10 (the most severe symptom). Higher scores indicate greater symptom severity.
Measured: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention
Hand Grip Strength
Hand grip strength will be assessed using the Jamar hydraulic hand dynamometer, a commonly used and reliable tool for evaluating maximal grip force. Participants will be seated upright with back support, hips and knees flexed at 90°, feet supported on the floor, shoulder adducted, elbow flexed at 90°, and wrist positioned in 15°-30° extension and 0°-15° ulnar deviation. After demonstration of the measurement procedure, participants will be instructed to squeeze the dynamometer maximally for 3 seconds. Three measurements will be performed with 1-minute intervals, and the mean value will be recorded in kg/f.
Measured: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
The Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) is a self-reported questionnaire used to assess upper extremity function, disability, and symptoms. The questionnaire consists of 11 items evaluating difficulty during physical activities, the impact of upper extremity problems on daily and social activities, sleep, pain, and numbness. Each item is scored from 1 to 5, and the total score is converted to a scale ranging from 0 to 100. Higher scores indicate greater disability and more severe upper extremity impairment.
Measured: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm)
The Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm) is a disease-specific questionnaire developed to assess quality of life in individuals with upper extremity lymphedema. The questionnaire consists of four domains, including function, appearance/body image, symptoms, and mood, as well as one overall quality of life item. Each domain item is rated on a 4-point Likert scale (1 = not at all, 4 = very much), with higher scores indicating poorer quality of life. The overall quality of life item is rated on a scale from 0 (worst quality of life) to 10 (best quality of life). Mean scores are calculated for each domain, and domain scores together with the overall quality of life score are used for evaluation.
Measured: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Breast Cancer-Related Lymphedema Self-Care Scale
The Breast Cancer-Related Lymphedema Self-Care Scale is a questionnaire developed to assess self-care behaviors in individuals with breast cancer-related lymphedema. The scale consists of 31 items and four subdomains, which are rated using a 4-point Likert scale. Total scores range from 31 to 124, with higher scores indicating better self-care practices.
Measured: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Lymphedema Self-Management Adherence Monitoring Form
The Lymphedema Self-Management Adherence Monitoring Form is a daily tracking form developed to evaluate participants' adherence to self-management practices, including exercise, self-lymphatic drainage (SLD), and compression garment use. Participants will record whether they performed the exercise and SLD program, as well as the duration and number of sessions. Compression garment use will be recorded based on daily usage and duration of wear (hours). Adherence will be evaluated based on data collected throughout the 8-week intervention period and the subsequent 4-week follow-up period.
Measured: From baseline to Week 12 (during the 8-week intervention period and 4-week follow-up period)
Patient Satisfaction with Tele-rehabilitation Program
Patient satisfaction with the tele-rehabilitation program will be assessed using a single-item 0-10 satisfaction rating scale developed by the researchers. Participants will rate their overall satisfaction with the tele-rehabilitation program from 0 (not satisfied at all) to 10 (completely satisfied). Higher scores indicate greater satisfaction.
Measured: Week 8 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start7 Sep 2026
- Primary completion2 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-Related LymphedemaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlayda Gürsoy, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794904
- Sponsor's protocol ID
- E-29624016-050.99-3971805
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07794904
- Acronym / sponsor ID
- E-29624016-050.99-3971805
- Conditions
- Breast Cancer-Related Lymphedema, Lymphedema
- Keywords
- Breast Cancer-Related Lymphedema, Lymphedema, Tele-rehabilitation, Exercise, Self-Lymphatic Drainage, Self-Management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Aug 2026 (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.
A total of 64 women, aged between 20 and 65 years, diagnosed with stage I or II breast cancer-related lymphedema and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Medical Faculty, will be included in our thesis study, which is planned to be prospective, randomized, and single-blind. Participants will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and written informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Participant assessment and follow-up forms will be completed before and after treatment. Participants who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention group or the control group by a computer program.
All participants will receive a face-to-face education session about breast cancer-related lymphedema, including exercise, self-lymphatic drainage, skin care, compression garment use, and self-management, together with an educational brochure. Participants in both groups will be asked to continue wearing their prescribed compression garments throughout the study. In addition to this education, the intervention group (G1) will join live Zoom sessions with the study physician three times a week for 8 weeks to perform the exercise and self-lymphatic drainage program under real-time supervision. Each session will include approximately 30 minutes of therapeutic exercises followed by 15 minutes of self-lymphatic drainage.
The control group (G2) will receive the same exercise and self-lymphatic drainage program in brochure format, including written instructions and illustrations. Participants will be asked to perform the exercise and self-lymphatic drainage program at home three times a week for 8 weeks without live online supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage ProgramIn addition to a face-to-face education session and educational brochure, participants will receive the exercise and self-lymphatic drainage program through live Zoom sessions with the study physician three times a week for 8 weeks. |
| Control Group | Active comparator | Other: Home-Based Exercise and Self-Lymphatic Drainage ProgramFace-to-face education session and educational brochure with the same exercise and self-lymphatic drainage program performed as a home-based program three times a week for 8 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female participants between 20 and 65 years of age
- History of unilateral breast cancer surgery including axillary lymph node dissection
- Completion of breast cancer treatments, including surgery, radiotherapy, and chemotherapy, with at least 3 months elapsed since treatment completion
- Diagnosis of stage I or stage II upper extremity lymphedema according to the International Society of Lymphology (ISL) classification
- Presence of at least 5% volume difference between the affected and unaffected upper extremities
Key exclusion criteria (7 listed)
- Presence of uncontrolled hypertension, pulmonary edema, or severe cardiovascular disease
- Presence of psychiatric or cognitive impairment that may interfere with study participation or adherence
- Presence of stage III lymphedema according to the ISL classification
- Presence of skin lesions such as papilloma or hyperkeratosis in the lymphedematous area
- History of bilateral breast cancer
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 |
|---|---|---|
| Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage ProgramThe exercise and self-lymphatic drainage program will be performed under live online supervision. | Other | Intervention Group |
| Home-Based Exercise and Self-Lymphatic Drainage ProgramThe same exercise and self-lymphatic drainage program will be performed at home using an educational brochure. | Other | Control Group |
Primary outcome
Change from Baseline in Affected Upper Extremity Volume
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention)
Limb volume is an objective measure used to evaluate swelling associated with upper extremity lymphedema. Bilateral arm circumference measurements will be obtained using a low-stretch measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle. Bilateral upper limb volume will be calculated indirectly using the truncated cone formula. The change from baseline in affected upper extremity volume will be evaluated as the primary outcome. Treatment response will additionally be assessed using the excess volume difference between the affected and unaffected limbs and the percentage change in excess volume (PCEV). Lymphedema severity will also be classified according to the excess limb volume difference as minimal (5-<20% increase), moderate (20-40% increase), and severe (>40% increase).
8 secondary outcomes
Lymphedema Stage
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Visual Analog Scale (VAS) for Lymphedema Symptom Severity
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention
Hand Grip Strength
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm)
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Breast Cancer-Related Lymphedema Self-Care Scale
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
Lymphedema Self-Management Adherence Monitoring Form
Time frame: From baseline to Week 12 (during the 8-week intervention period and 4-week follow-up period)
Patient Satisfaction with Tele-rehabilitation Program
Time frame: Week 8 (end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program and Home-Based Exercise and Self-Lymphatic Drainage Program in people with Breast Cancer-Related Lymphedema and Lymphedema, run by Istanbul 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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 in Affected Upper Extremity Volume (time frame: Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.