Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer

Last updated: December 16, 2024
Sponsor: Association Francaise pour la Recherche Thermale
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Scar Tissue

Treatment

Thermal cure with a primary dermatological indication

Clinical Study ID

NCT05874492
2023-A00091-44
  • Ages > 18
  • Female

Study Summary

FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.

The aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and/or soft tissues at least 6 months after the end of postoperative radiotherapy for breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Age ≥ 18 years

  • In situ or invasive breast cancer

  • DLQI ≥ 6 (at least moderate effect on patient's life)

  • General status WHO 0-1

  • Post-operative radiotherapy completed at least 6 months ago (with no maximum postradiotherapy delay)

  • Unilateral breast radiotherapy

  • Skin or soft tissue toxicity (- modules: Skin and subcutaneous tissue disorders /Musculoskeletal disorders / Reproductive organs and breast disorders) CTCAE v4.0grade ≥ 2

  • No inflammatory or infectious flare at inclusion

  • Female of childbearing potential: negative urine pregnancy test at inclusion

  • Patient informed and signed consent

  • Affiliation to a social security systeme or equivalent

Exclusion

Exclusion Criteria:

  • Progressive phase of cancer

  • Metastatic disease

  • Patient undergoing specific treatment for breast cancer (except adjuvant hormonetherapy and/or adjuvant herceptin)

  • Bilateral breast/parietal radiotherapy

  • Breast prosthesis wearer

  • Obvious skin ulceration in the treated breast

  • Contraindication to spa treatment (acute inflammatory disease, active infections,heart failure with NYHA stage > 1, chronic respiratory failure, labile hypertension,bullous disease)

  • Chronic progressive dermatological disease

  • Women who are pregnant or likely to become pregnant within 6 months or who arebreastfeeding

  • Persons deprived of liberty or under guardianship

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Thermal cure with a primary dermatological indication
Phase:
Study Start date:
January 29, 2024
Estimated Completion Date:
April 30, 2026

Study Description

Radiation-induced fibrosis is an equivalent of an "orphan disease", in which oncologists have only recently shown interest, despite its prevalence. No study on the medical service provided by crenotherapy has been published in late radiation-induced fibrosis, which shares a common pathophysiology and medico-psycho-social sequelae with the sequelae of burns.

Chronic progressive dermatoses are part of the 12 main therapeutic orientations of medical thermalism. In particular, burn scars are a very current indication. Crenotherapy allows the attenuation, or even the disappearance of: pruritus and dysesthesia, local inflammation, hypertrophy and sclerosis and favours the recovery of chronic superficial erosions. Fibrous scars, even old ones, respond favourably to thermal treatments. The thermal treatment combines baths which have a sedative, muscle-relaxing effect and which favour joint mobilisation, sprays which have a decongestant effect and above all thread-like showers which are carried out by jets of thermal water under high pressure for several minutes.

The primary endpoint is the self-assessment by the patient of the dermatological quality of life by the DLQI score at 6 months after the end of the treatment compared between the intervention group (immediate treatment) and the control group (delayed treatment after 6 months).

Connect with a study center

  • Clinique Tivoli-Ducos

    Bordeaux, 33000
    France

    Active - Recruiting

  • Institut de Cancérologie de Bourgogne

    Dijon, 21000
    France

    Active - Recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38000
    France

    Active - Recruiting

  • Centre de cancérologie de la Sarthe

    Le Mans, 72000
    France

    Site Not Available

  • Institut Rafael

    Levallois Perret,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69973
    France

    Site Not Available

  • Centre Azuréen de Cancérologie

    Mougins,
    France

    Active - Recruiting

  • Centre Eugène Marquis

    Rennes, 35000
    France

    Active - Recruiting

  • Centre Hospitalier Roanne

    Roanne,
    France

    Active - Recruiting

  • CHU Saint Etienne

    Saint Etienne,
    France

    Active - Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519
    France

    Active - Recruiting

  • Centre François Baclesse

    Esch-sur-Alzette, L-4240
    Luxembourg

    Site Not Available

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