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.
I.R.C.C.S. Fondazione Santa Lucia
36 participants
Nov 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria1
- Concurrent Diseases: Concomitant diseases that may interfere with the study.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07257679