An interventional study of Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program and Home-Based Exercise and Self-Lymphatic Drainage Program in Breast Cancer-Related Lymphedema and Lymphedema, sponsored by Istanbul University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Istanbul University · Not applicable, Interventional, and Treatment
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.
124 studies on the registry are indexed under Breast Cancer Lymphedema; 40 are open to participants now.
This study's planned enrollment of 64 is above the median of 48 across 97 interventional studies indexed under Breast Cancer Lymphedema.
Browse Breast Cancer Lymphedema studies →Istanbul University is the lead sponsor of 511 studies on the registry; 78 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program
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.
Other: Home-Based Exercise and Self-Lymphatic Drainage Program
The exercise and self-lymphatic drainage program will be performed under live online supervision.
The same exercise and self-lymphatic drainage program will be performed at home using an educational brochure.
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).
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention)
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.
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
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.
Time frame: 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.
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)
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.
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)
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.
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
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.
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
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.
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
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.
Time frame: Week 8 (end of intervention)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 1 month after the start.
Of 66 non-industry interventional studies with no phase under Breast Cancer Lymphedema, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 1 month is below that.
Counting every sponsor, half of 69 studies reached it within 18 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.