Gentle Touch therapy for arm lymphedema after breast cancer surgery
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.
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 |
| Enrollment | 36 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | Female |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia Academic / other |
| Locations | 2 sites (Roma, RM and 1 other locations) |
| Trial ID | NCT07257679 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, RM and 1 other locations
- Santa Lucia Foundation IRCCS — Roma, Rm, Italy (Active_not_recruiting)
- Santa Lucia Foundation, Scientific Institute for Research and Health Care — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Diego Piatti, PT
- Email: d.piatti@hsantalucia.it
- Phone: 0651501479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.