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). 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.

NCT Number	NCT07257679
Lead Sponsor	I.R.C.C.S. Fondazione Santa Lucia Collaborators: Comitato A.N.D.O.S. di Roma odv.
Conditions	Lymphedema, Breast Cancer
Enrollment	36 participants
Start Date	2025-11-01
Primary Completion	2027-01-15 (estimated)
Study Completion	2027-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-02