Status:

RECRUITING

Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer

Lead Sponsor:

Association Francaise pour la Recherche Thermale

Collaborating Sponsors:

Floralis

Conditions:

Fibrosis

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ...

Detailed 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 crenothe...

Eligibility Criteria

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

Key Trial Info

Start Date :

January 29 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT05874492

Start Date

January 29 2024

End Date

December 1 2027

Last Update

April 13 2026

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Clinique Tivoli-Ducos

Bordeaux, France, 33000

2

Centre Hospitalier Intercommunal Créteil

Créteil, France, 94000

3

Institut de Cancérologie de Bourgogne

Dijon, France, 21000

4

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, France, 38000

Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer | DecenTrialz