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.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Santa Lucia Foundation IRCCS
ACTIVE_NOT_RECRUITING
Roma
Santa Lucia Foundation, Scientific Institute for Research and Health Care
RECRUITING
Roma
Contact Information
Primary
Diego Piatti, PT
d.piatti@hsantalucia.it
0651501479
Time Frame
Start Date:2025-11-01
Estimated Completion Date:2027-11-01
Participants
Target number of participants:36
Treatments
Experimental: Gentle Touch (GT) Lymphatic Drainage + Usual Care
Participants in this arm will receive the Gentle Touch (GT) lymphatic drainage technique, which is based on the ANDOS manual technique, in addition to their existing rehabilitation pathway. The GT is a tactile stimulus applied to the skin aimed at promoting relaxation, improving pain, sleep management, and therapeutic participation. The treatment involves 10 sessions administered with a bi-weekly frequency.
Active_comparator: Passive Mobilization and Active-Assisted Exercises + Usual Care
Participants in this arm will receive 10 sessions of passive mobilization and active-assisted exercises for the upper limb. This is provided in addition to the existing rehabilitation program. The sessions will be carried out with the same frequency (bi-weekly) as the experimental group.