Gentle Touch for Post-Mastectomy Lymphedema
ConditionLymphedema, Breast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age30-75
SponsorI.R.C.C.S. Fondazione Santa Lucia
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Concurrent Diseases: Concomitant diseases that may interfere with the study.
Trial design
Treatments tested in this trial
- Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
- Passive Mobilization and Active-Assisted Exercises for the Upper Limb
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
I.R.C.C.S. Fondazione Santa Lucia
Lead sponsor
Comitato A.N.D.O.S. di Roma odv.
Collaborator
Source ClinicalTrials.gov