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New treatment option for Fibrosis
Official title Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer
ClinicalTrials.gov ID: NCT05874492
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Créteil, France
- Dijon, France
- Grenoble, France
- Levallois-Perret, France
- Marseille, France
- Mougins, France
- Rennes, France
- Roanne, France
- Saint-Etienne, France
- Vandœuvre-lès-Nancy, France
- Esch-sur-Alzette, Luxembourg
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Créteil, France; Dijon, France; Grenoble, France; Levallois-Perret, France; Marseille, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.