Gentle Touch for Post-Mastectomy Lymphedema
This is a single-blind, parallel-group Randomized Controlled Trial (RCT) comparing the efficacy of a specialized manual technique, Gentle Touch (GT), versus a control intervention, both added to the usual rehabilitative care. The study investigates 36 women aged 30 to 75 with Breast Cancer-Related Lymphedema (BCRL). Th
| Condition(s) | Lymphedema, Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | This is a single-blind, parallel-group Randomized Controlled Trial (RCT) comparing the efficacy of a specialized manual technique, Gentle Touch (GT), versus a control intervention, both added to the usual rehabilitative care. The study investigates 36 women aged 30 to 75 with Breast Cancer-Related Lymphedema (BCRL). The primary objective is to evaluate the reduction of lymphedema volume in the upper limb. Secondary objectives include assessing the improvement in patients' quality of life and the potential reduction in care burden and costs. The treatment protocol involves 10 bi-weekly sessions over 5 weeks. |
| Who can participate | Inclusion Criteria: * Gender: Women. * Age: Between 30 and 75 years old * Surgical History: Women who have undergone surgery for breast cancer (BC). This includes being subjected to one of the following interventions: Axillary dissection with removal of all 3 lymph node levels; Axillary dissection with removal of only one lymph node level; Removal of the sentinel lymph node only. * Clinical Lymphedema: Clinically evaluated lymphedema symptoms, defined as a circumference difference of greater than 20mm between the two arms Exclusion Criteria: * Concurrent Diseases: Concomitant diseases that may interfere with the study. |
| Ages | 30 Years to 75 Years |
| Sex | Female |
| Lead sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Locations | Roma, RM, Italy; Roma, RM, Italy |
| Start date | 2025-11-01 |
| NCT ID | NCT07257679 |
| Official listing | https://clinicaltrials.gov/study/NCT07257679 |