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Gentle Touch for Post-Mastectomy Lymphedema

RecruitingPhase 4Ages 30 Years - 75 YearsFemaleI.R.C.C.S. Fondazione Santa Lucia
NCT07257679 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
  • Passive Mobilization and Active-Assisted Exercises for the Upper Limb
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Where

2 sites
Santa Lucia Foundation IRCCS
Roma, Italy
Santa Lucia Foundation, Scientific Institute for Research and Health Care
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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