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.
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Change of Upper Limb Lymphedema Volume
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change of Upper Limb Lymphedema Volume
Time Frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)
The volume of lymphedema will be measured volumetrically, comparing the difference in volume of the affected limb relative to the contralateral limb.
Secondary Outcomes
- Change in Lymphedema-Specific Quality of Life (LYMQOL)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))
- Change in Upper Limb Function and Disability (DASH)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))
- Change in General Health (SF-36)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))
- Change in Well-being (PROMIS-29)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))