Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
NCT Number: NCT07794904
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.
Trial opening soon.
Get Notified20 year–65 year
Female
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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
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 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)
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)
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)
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: From baseline to Week 12 (during the 8-week intervention period and 4-week follow-up period)
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: Week 8 (end of intervention)
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.
Contact information is provided by the study sponsor or research team.
Istanbul University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07026292
Breast Cancer Invasive, Breast Cancer Lymphedema
View Trial DetailsNCT07365618
Behavior, Breast Cancer Lymphedema
Lisbon, Portugal
View Trial DetailsNCT07086053
Breast Cancer Lymphedema, Breast Cancer-Related Lymphedema
View Trial DetailsNCT07585253
Autonomic Dysfunction, Autonomic Nervous System Diseases
Ankara, Turkey (Türkiye)
View Trial Details