RecruitingPhase 4

Gentle Touch for Post-Mastectomy Lymphedema

Italy36 participantsStarted 2025-11-01

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change of Upper Limb Lymphedema Volume

Timeframe: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)

Trial details

NCT IDNCT07257679

SponsorI.R.C.C.S. Fondazione Santa Lucia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-15

Contact for this trial

Diego Piatti, PT

0651501479 d.piatti@hsantalucia.it

View on ClinicalTrials.gov More Lymphedema, Breast Cancer trials