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Gentle Touch for Post-Mastectomy Lymphedema
Sponsor: I.R.C.C.S. Fondazione Santa Lucia
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.
Official title: The Effects of 'Gentle Touch' in the Management of Lymphedema in Women Treated for Breast Cancer: A Preliminary Single-blind, Parallel-group Randomized Controlled Trial.
Key Details
Gender
FEMALE
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-11-01
Completion Date
2027-11-01
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
This intervention involves the application of a specific tactile stimulus (Gentle Touch) to the skin. This stimulus is designed to promote relaxation, alleviate social isolation and stress, and provide emotional support. The goal is to stimulate fluid movement in the skin, increasing lymphatic flow, attenuating fibrosis, and reducing pain. This approach (GT-based ANDOS technique) is added to the participant's existing rehabilitation program. The intervention is administered by a specifically trained physiotherapist. Dosage: 10 sessions. Frequency: Bi-weekly.
Passive Mobilization and Active-Assisted Exercises for the Upper Limb
This intervention consists of passive mobilization and active-assisted exercises for the affected upper limb. This intervention is given in addition to the participant's existing rehabilitation program. This is the control intervention to which the experimental GT approach is compared. It is administered by a specifically trained physiotherapist. Dosage: 10 sessions. Frequency: Bi-weekly (same as the experimental group).
Locations (2)
Santa Lucia Foundation IRCCS
Roma, RM, Italy
Santa Lucia Foundation, Scientific Institute for Research and Health Care
Roma, RM, Italy