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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).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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

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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07794904
Study groupRoleWhat they receive
Intervention GroupExperimentalIn 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 GroupActive comparatorFace-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.

  1. 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)
  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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.

  1. First posted31 Aug 2026
  2. Study start7 Sep 2026
  3. Primary completion2 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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)
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

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