Gentle Touch for Post-Mastectomy Lymphedema
ConditionLymphedema, Breast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age30-75
SponsorI.R.C.C.S. Fondazione Santa Lucia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Concurrent Diseases: Concomitant diseases that may interfere with the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
Other interventionThis 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.
Passive Mobilization and Active-Assisted Exercises for the Upper Limb
Other interventionThis 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).
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Gentle Touch (GT) Lymphatic Drainage + Usual CareExperimental treatment 1 intervention
Group B: Passive Mobilization and Active-Assisted Exercises + Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
I.R.C.C.S. Fondazione Santa Lucia
Lead sponsor
Comitato A.N.D.O.S. di Roma odv.
Collaborator
Source ClinicalTrials.gov