Gentle Touch therapy for arm lymphedema after breast cancer surgery
Official title: 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.
Run by LIFE - Research and Care Institute - Santa Lucia IRCCS · NCT07257679 · Data updated 2026-11-12
We will test whether adding Gentle Touch lymphatic drainage to usual rehabilitation reduces arm swelling in women aged 30–75 with breast cancer–related lymphedema.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 30 Years to 75 Years |
| Sex | Women only |
| Enrollment | 36 (estimated) |
| Sponsor | LIFE - Research and Care Institute - Santa Lucia IRCCS Academic / other |
| Locations | 2 sites (Roma, RM and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | January 15, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07257679 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 30–75 who have had breast cancer surgery with axillary intervention and have clinically evident unilateral lymphedema defined by a >20 mm arm circumference difference are ideal candidates.
✕Probably not a fit
Patients with other medical conditions that interfere with treatment, those without the specified arm circumference difference, men, or those unable to attend in-person sessions are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-blind, parallel-group randomized controlled trial enrolls 36 women with breast cancer–related upper limb lymphedema and compares a Gentle Touch (GT) manual lymphatic drainage technique to a control intervention, both given alongside usual rehabilitative care. Participants receive 10 sessions delivered twice weekly over five weeks, with primary outcome measured as change in limb volume. Secondary outcomes include quality of life measures and analyses of care burden and health care costs, including potential reductions in future treatment needs. Eligible participants are women aged 30–75 with a clinical arm circumference difference >20 mm following axillary surgery for breast cancer.
Why it matters
Potential benefit: If successful, the approach could reduce arm swelling, improve quality of life, and lower the need for ongoing lymphedema care and associated costs for affected women.
How similar studies have gone: Manual lymphatic drainage has supporting evidence for lymphedema, but the specific Gentle Touch tactile approach is a more novel variation with limited direct randomized evidence to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Santa Lucia Foundation, Scientific Institute for Research and Health Care
Roma, Rm, Italy Recruiting -
Santa Lucia Foundation IRCCS
Roma, Rm, Italy Active not recruiting
Study contacts
- Study coordinator: Diego Piatti, PT
- Email: d.piatti@hsantalucia.it
- Phone: 0651501479
Similar studies
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This study will test whether the Dayspring wearable compression system helps move lymph and reduce arm swelling in adults with breast cancer–related lymphedema after lymphatic surgery.
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ESWT added to standard lymphedema care for breast cancer patients
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.