RecruitingPhase 4NCT07257679

Gentle Touch for Post-Mastectomy Lymphedema

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.

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

Enrollment

36 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphedema, Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a gentle massage technique for lymphedema (a condition causing arm swelling after breast cancer surgery) can reduce swelling and improve quality of life in women who have developed this complication. **You may be eligible if...** - You are a woman between 30 and 75 years old - You had breast cancer surgery that included axillary (underarm) lymph node removal - You have developed arm lymphedema (swelling) as a result **You may NOT be eligible if...** - You have active cancer or infection in the affected arm - You have had recent surgery or radiation to the affected area - You have conditions that make massage unsafe (e.g., blood clots, open wounds) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERGentle 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.

OTHERPassive 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

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