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Lymphedema, Breast CancerPhase 4GT-BCRLNCT07257679

Gentle Touch for Post-Mastectomy Lymphedema

A Phase 4 study testing Gentle Touch (GT) Lymphatic Drainage (ANDOS technique) and Passive Mobilization and Active-Assisted Exercises for the Upper Limb in people with Lymphedema, Breast Cancer, run by I.R.C.C.S. Fondazione Santa Lucia at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 75 years, women only
Conditions the study is for
Lymphedema, Breast Cancer
What is being tested?
Gentle Touch (GT) Lymphatic Drainage (ANDOS technique) and Passive Mobilization and Active-Assisted Exercises for the Upper Limb
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesItaly
Study dates
1 Nov 2025to 1 Nov 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Diego Piatti, PT contact

0651501479

d.piatti@hsantalucia.it

Italy2 sites, 1 recruiting

  • Santa Lucia Foundation IRCCS

    Roma, RM, 00179

    Active, not recruiting

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

    Roma, RM, 00179

    Recruiting

Other trials in Italy

About this study

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.

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.

Read the 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.

Being tested
Gentle Touch (GT) Lymphatic Drainage (ANDOS technique), Passive Mobilization and Active-Assisted Exercises for the Upper Limb
Keywords
Lymphedema, Breast Cancer, DLM, Gentle touch
Medical subject headings
Breast Cancer Lymphedema, Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Passive Mobilization and Active-Assisted Exercises for the Upper LimbOther

    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).

Study groups in NCT07257679
Study groupRoleWhat they receive
Gentle Touch (GT) Lymphatic Drainage + Usual CareExperimentalParticipants 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.
Receives: Other: Gentle Touch (GT) Lymphatic Drainage (ANDOS technique)
Passive Mobilization and Active-Assisted Exercises + Usual CareActive comparatorParticipants 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.
Receives: Other: Passive Mobilization and Active-Assisted Exercises for the Upper Limb

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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)

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start1 Nov 2025
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07257679
Sponsor's protocol ID
387/SL/25
Acronym
GT-BCRL
Status last verified
Oct 2025
First submitted
17 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35759976

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gentle Touch (GT) Lymphatic Drainage (ANDOS technique) and Passive Mobilization and Active-Assisted Exercises for the Upper Limb in people with Lymphedema, Breast Cancer, run by I.R.C.C.S. Fondazione Santa Lucia at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Diego Piatti, PT (0651501479, d.piatti@hsantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Upper Limb Lymphedema Volume (time frame: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07257679, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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