NCT07257679

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: I.R.C.C.S. Fondazione Santa Lucia · Academic / Other
• Sex: Female
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Breast cancer (BC) treatment often leads to lymphedema, a condition affecting up to 40% of survivors and negatively impacting their quality of life due to swelling, pain, and functional limitations. Manual Lymphatic Drainage (MLD) is a proven treatment method. This study focuses on the Gentle Touch (GT) approach, a specific tactile stimulus applied to the skin intended to promote emotional support, relaxation, and stress alleviation. The Primary Objective is to evaluate the efficacy of the Gentle Touch-based MLD in reducing the volume of upper limb lymphedema in women who have undergone surgery for BC. The Secondary Objectives are to evaluate whether the GT approach can improve the quality of life of the treated women, including emotional, psychological, and social aspects and reduce the care burden and costs compared to the control group, potentially by reducing the number of treatments required compared to conventional approaches.

Conditions

• Lymphedema, Breast Cancer

Interventions

Type	Name	Description
OTHER	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.
OTHER	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).

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-01-15
• Completion: 2027-11-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

2 sites across 1 country: Italy