Evaluating spa therapy for skin fibrosis after breast cancer radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to assess the medical benefits of dermatologically oriented spa therapy on patients experiencing severe skin and soft tissue fibrosis following postoperative radiotherapy for breast cancer. It is a controlled, randomized, multicenter trial where participants will be divided into an intervention group receiving immediate treatment and a control group receiving delayed treatment. The primary outcome will be measured using the Dermatology Life Quality Index (DLQI) score six months post-treatment to evaluate improvements in quality of life. The study focuses on the effects of thermal treatments, which include baths and high-pressure water jets, on chronic skin conditions resulting from radiation therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* In situ or invasive breast cancer or cancer of the upper aerodigestive tract
* DLQI ≥ 6 (at least moderate effect on patient's life)
* General status WHO 0-1
* Radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)
* Unilateral breast radiotherapy for breast cancer patients
* Skin or soft tissue toxicity (- modules: Skin atrophy, fibrosis of deep connective tissues, fibrosis of superficial soft tissues) CTCAE v4.0 grade ≥ 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 Criteria:

* Progressive phase of cancer
* Metastatic disease
* Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and/or adjuvant herceptin)
* Bilateral breast/parietal radiotherapy
* Breast prosthesis wearer for breast cancer patients
* Patient with a tracheostomy for patients with head and neck cancer
* Obvious skin ulceration in the site of interest
* 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 are breastfeeding
* Persons deprived of liberty or under guardianship

Where it's running

• Clinique Tivoli-Ducos
  Bordeaux, France Recruiting
• Centre Hospitalier Intercommunal Créteil
  Créteil, France Recruiting
• Institut de Cancérologie de Bourgogne
  Dijon, France Recruiting
• Centre Hospitalier Universitaire Grenoble Alpes
  Grenoble, France Recruiting
• Groupe Hospitalier Mutualiste de Grenoble
  Grenoble, France Recruiting
• Institut Rafael
  Levallois-Perret, France Recruiting

Study contacts

• Principal investigator: Guillaume Vogin — Centre François Baclesse
• Study coordinator: Nans FUSTIER
• Email: nans.fustier@univ-grenoble-alpes.fr
• Phone: 0476765040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.