Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema

N/AActive Not RecruitingNCT07794904

Istanbul University64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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 Exclusion Criteria * 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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.