NCT07257679 Gentle Touch for Post-Mastectomy Lymphedema
| NCT ID | NCT07257679 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Condition | Lymphedema, Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 36 participants in total. It began in 2025-11-01 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07257679 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 75 Years, studying Lymphedema, Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07257679 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07257679 currently recruiting?
Yes, NCT07257679 is actively recruiting participants. Contact the research team at d.piatti@hsantalucia.it for enrollment information.
Where is the NCT07257679 trial being conducted?
This trial is being conducted at Roma, Italy, Roma, Italy.
Who is sponsoring the NCT07257679 clinical trial?
NCT07257679 is sponsored by I.R.C.C.S. Fondazione Santa Lucia. The trial plans to enroll 36 participants.
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