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NCT05874492Recruiting

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

Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer in Remission

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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 radiotherapy for breast cancer or UADT (Upper Aerodigestive Tract) cancer.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
110 (estimated)
First submitted
13 Apr 2023
Start date
29 Jan 2024
Primary completion date
Dec 2026
Lead sponsor
Association Francaise pour la Recherche Thermale
NCT number
NCT05874492

What you commit to

  • Study type: Interventional
  • Planned participants: 110
  • From 29 Jan 2024 to the primary completion date, Dec 2026
  • 13 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Bilateral breast/parietal radiotherapy

Other illness

  • Progressive phase of cancer
  • Metastatic disease
  • Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and/or adjuvant herceptin)
  • Breast prosthesis wearer for breast cancer patients
  • Patient with a tracheostomy for patients with head and neck cancer
  • 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

Other

  • Obvious skin ulceration in the site of interest
  • Women who are pregnant or likely to become pregnant within 6 months or who are breastfeeding
  • Persons deprived of liberty or under guardianship

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinique Tivoli-Ducos
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BordeauxFranceRecruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceRecruiting
Institut de Cancérologie de Bourgogne
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DijonFranceRecruiting
Centre hospitalier universitaire Grenoble-Alpes
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GrenobleFranceRecruiting
Groupe Hospitalier Mutualiste de Grenoble
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GrenobleFranceRecruiting
Institut Rafael
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Levallois-PerretFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Centre Azuréen de Cancérologie
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MouginsFranceRecruiting
Centre Eugène Marquis
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RennesFranceRecruiting
Centre Hospitalier Roanne
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RoanneFranceRecruiting
CHU Saint-Etienne
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Saint-EtienneFranceRecruiting
Institut de Cancérologie de Lorraine
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Vandœuvre-lès-NancyFranceRecruiting
Centre François Baclesse
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Esch-sur-AlzetteLuxembourgNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.