Clinical trial · Interventional
Gentle Touch for Post-Mastectomy Lymphedema
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.
NCT07257679CI-TRIAL-00098194GT-BCRLrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema, Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gentle Touch (GT) Lymphatic Drainage (ANDOS technique) | Other | — | UNRESOLVED |
| Passive Mobilization and Active-Assisted Exercises for the Upper Limb | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gentle Touch (GT) Lymphatic Drainage + Usual Care
- description
- 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.
- interventionNames
- Other: Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
- type
- ACTIVE_COMPARATOR
- label
- Passive Mobilization and Active-Assisted Exercises + Usual Care
- description
- 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.
- interventionNames
- Other: Passive Mobilization and Active-Assisted Exercises for the Upper Limb
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDLoibl 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
- BACKGROUNDFu 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
- BACKGROUNDThompson 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
- BACKGROUNDSezer 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