Gentle Touch for Post-Mastectomy Lymphedema

Official title

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.

Overview

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.

Detailed description

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.

Interventions

• Other Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
  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 tra
• Other Passive Mobilization and Active-Assisted Exercises for the Upper Limb
  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).

Primary outcome measures

• Change of Upper Limb Lymphedema Volume [Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)]

Secondary outcome measures (4)

• Change in Lymphedema-Specific Quality of Life (LYMQOL) [Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)]
• Change in Upper Limb Function and Disability (DASH) [Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)]
• Change in General Health (SF-36) [Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)]
• Change in Well-being (PROMIS-29) [Time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 2 centers

• Santa Lucia Foundation IRCCS — Roma
• Santa Lucia Foundation, Scientific Institute for Research and Health Care — Roma

Publications

• Loibl S, Andre F, Bachelot T, Barrios CH, Bergh J, Burstein HJ, Cardoso MJ, Carey LA, Dawood S, Del Mastro L, Denkert C, Fallenberg EM, Francis PA, Gamal-Eldin H, Gelmon K, Geyer CE, Gnant M, Guarneri V, Gupta S, Kim SB, Krug D, Martin M, Meattini I, Morrow M, Janni W, Paluch-Shimon S, Partridge A, Poortmans P, Pusztai L, Regan MM, Sparano J, Spanic T, Swain S, Tjulandin S, Toi M, Trapani D, Tutt PMID 38101773
• Fu MR, Ridner SH, Hu SH, Stewart BR, Cormier JN, Armer JM. Psychosocial impact of lymphedema: a systematic review of literature from 2004 to 2011. Psychooncology. 2013 Jul;22(7):1466-84. doi: 10.1002/pon.3201. Epub 2012 Oct 9. PMID 23044512
• Thompson B, Gaitatzis K, Janse de Jonge X, Blackwell R, Koelmeyer LA. Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature. J Cancer Surviv. 2021 Apr;15(2):244-258. doi: 10.1007/s11764-020-00928-1. Epub 2020 Aug 15. PMID 32803533
• Sezer Efe Y, Erdem E, Caner N, Gunes T. The effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing. Complement Ther Clin Pract. 2022 Aug;48:101622. doi: 10.1016/j.ctcp.2022.101622. Epub 2022 Jun 22. PMID 35759976

Identifiers

NCT: NCT07257679 · 387/SL/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗