Gentle Touch for Post-Mastectomy Lymphedema (GT-BCRL)

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

Status and phase: Enrolling; Phase 4

Conditions: Lymphedema, Breast Cancer

Treatments: Other: Gentle Touch (GT) Lymphatic Drainage (ANDOS technique); Other: Passive Mobilization and Active-Assisted Exercises for the Upper Limb

Study type: Interventional

Funder types: Other

Identifiers

NCT07257679

387/SL/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Gentle Touch (GT) Lymphatic Drainage + Usual Care

Experimental group

Description:

Participants in this arm will receive the Gentle Touch (GT) lymphatic drainage technique, which is based on the ANDOS manual technique, in addition to their existing rehabilitation pathway. The GT is a tactile stimulus applied to the skin aimed at promoting relaxation, improving pain, sleep management, and therapeutic participation. The treatment involves 10 sessions administered with a bi-weekly frequency.

Treatment:

Other: Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)

Passive Mobilization and Active-Assisted Exercises + Usual Care

Active Comparator group

Description:

Participants in this arm will receive 10 sessions of passive mobilization and active-assisted exercises for the upper limb. This is provided in addition to the existing rehabilitation program. The sessions will be carried out with the same frequency (bi-weekly) as the experimental group.

Treatment:

Other: Passive Mobilization and Active-Assisted Exercises for the Upper Limb