Actively Recruiting
Gentle Touch for Post-Mastectomy Lymphedema
Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2025-12-02
36
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
I.R.C.C.S. Fondazione Santa Lucia
Lead Sponsor
C
Comitato A.N.D.O.S. di Roma odv.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Gentle Touch for Post-Mastectomy Lymphedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender
- Age between 30 and 75 years old
- History of breast cancer surgery including axillary dissection or sentinel lymph node removal
- Clinically evaluated lymphedema with arm circumference difference greater than 20 mm
You will not qualify if you...
- Presence of other diseases that may interfere with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Santa Lucia Foundation IRCCS
Roma, RM, Italy, 00179
Active, Not Recruiting
2
Santa Lucia Foundation, Scientific Institute for Research and Health Care
Roma, RM, Italy, 00179
Actively Recruiting
Research Team
D
Diego Piatti, PT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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