A Phase 4 interventional study of Gentle Touch (GT) Lymphatic Drainage (ANDOS technique) and Passive Mobilization and Active-Assisted Exercises for the Upper Limb in Lymphedema, Breast Cancer, sponsored by I.R.C.C.S. Fondazione Santa Lucia. Recruiting at 2 sites in Italy. Open to female participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by I.R.C.C.S. Fondazione Santa Lucia · Phase 4, Interventional, and Treatment
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.
Breast cancer (BC) treatment often leads to lymphedema, a condition affecting up to 40% of survivors and negatively impacting their quality of life due to swelling, pain, and functional limitations. Manual Lymphatic Drainage (MLD) is a proven treatment method. This study focuses on the Gentle Touch (GT) approach, a specific tactile stimulus applied to the skin intended to promote emotional support, relaxation, and stress alleviation.
The Primary Objective is to evaluate the efficacy of the Gentle Touch-based MLD in reducing the volume of upper limb lymphedema in women who have undergone surgery for BC.
The Secondary Objectives are to evaluate whether the GT approach can improve the quality of life of the treated women, including emotional, psychological, and social aspects and reduce the care burden and costs compared to the control group, potentially by reducing the number of treatments required compared to conventional approaches.
124 studies on the registry are indexed under Breast Cancer Lymphedema; 40 are open to participants now.
This study's planned enrollment of 36 is below the median of 48 across 97 interventional studies indexed under Breast Cancer Lymphedema.
Browse Breast Cancer Lymphedema studies →I.R.C.C.S. Fondazione Santa Lucia is the lead sponsor of 56 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
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.
Other: Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
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.
Other: Passive Mobilization and Active-Assisted Exercises for the Upper Limb
This intervention involves the application of a specific tactile stimulus (Gentle Touch) to the skin. This stimulus is designed to promote relaxation, alleviate social isolation and stress, and provide emotional support. The goal is to stimulate fluid movement in the skin, increasing lymphatic flow, attenuating fibrosis, and reducing pain. This approach (GT-based ANDOS technique) is added to the participant's existing rehabilitation program. The intervention is administered by a specifically trained physiotherapist. Dosage: 10 sessions. Frequency: Bi-weekly.
This intervention consists of passive mobilization and active-assisted exercises for the affected upper limb. This intervention is given in addition to the participant's existing rehabilitation program. This is the control intervention to which the experimental GT approach is compared. It is administered by a specifically trained physiotherapist. Dosage: 10 sessions. Frequency: Bi-weekly (same as the experimental group).
Change of Upper Limb Lymphedema Volume
The volume of lymphedema will be measured volumetrically, comparing the difference in volume of the affected limb relative to the contralateral limb.
Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)
Change in Lymphedema-Specific Quality of Life (LYMQOL)
Measured using the Lymphoedema Quality of Life Questionnaire (LYMQOL) score. Scores on the LYMQOL range from 1 to 4 for each item, with a total score ranging from 21 to 84; higher scores indicate a worse quality of life.
Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)
Change in Upper Limb Function and Disability (DASH)
Measured using the total score of the Disability of the Arm Shoulder and Hand Questionnaire (DASH). DASH scores range from 0 to 100, with higher scores indicating greater disability and thus worse upper limb function and quality of life.
Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)
Change in General Health (SF-36)
Measured using the scores of the SF-36 Questionnaire general health. SF-36 scores range from 0 to 100; higher scores indicate better health status (i.e. better perceived quality of life / functioning)
Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)
Change in Well-being (PROMIS-29)
Measured using the scores of the PROMIS-29 Questionnaire, to assess general physical and mental health status. PROMIS-29 provides scores for seven health domains. For each domain, raw scores range from 4 to 20. Higher scores indicate better outcomes for physical function and social participation, and worse outcomes for pain, fatigue, depression, anxiety, and sleep disturbance.
Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)
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I.R.C.C.S. Fondazione Santa Lucia