Gentle Touch for Post-Mastectomy Lymphedema

NCT07257679 | Recruiting Phase 4

• 1 other identifier: 387/SL/25
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphedema, Breast Cancer

Keywords

Lymphedema; Breast Cancer; DLM; Gentle touch

Outcome Measures

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.

  Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)

Secondary Outcomes (4)

• Change in Lymphedema-Specific Quality of Life (LYMQOL)

  Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)

• Change in Upper Limb Function and Disability (DASH)

  Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)

• Change in General Health (SF-36)

  Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)

• Change in Well-being (PROMIS-29)

  Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)

Study Arms (2)

Gentle Touch (GT) Lymphatic Drainage + Usual Care

EXPERIMENTAL

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)

Passive Mobilization and Active-Assisted Exercises + Usual Care

ACTIVE COMPARATOR

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

Interventions

Gentle Touch (GT) Lymphatic Drainage (ANDOS technique) OTHER

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.

Gentle Touch (GT) Lymphatic Drainage + Usual Care

Passive Mobilization and Active-Assisted Exercises for the Upper Limb OTHER

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).

Passive Mobilization and Active-Assisted Exercises + Usual Care

Eligibility Criteria

• Age: 30 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concurrent Diseases: Concomitant diseases that may interfere with the study.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• Comitato A.N.D.O.S. di Roma odv.: collaborator

Study Sites (2)

Santa Lucia Foundation IRCCS

Roma, RM, 00179, Italy

ACTIVE NOT RECRUITING

Santa Lucia Foundation, Scientific Institute for Research and Health Care

Roma, RM, 00179, Italy

RECRUITING

Related Publications (4)

• 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 A, Xu B, Curigliano G, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024 Feb;35(2):159-182. doi: 10.1016/j.annonc.2023.11.016. Epub 2023 Dec 13. No abstract available.

  PMID: 38101773 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Diego Piatti, PT

CONTACT

0651501479; d.piatti@hsantalucia.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)