Evaluating spa therapy for skin fibrosis after breast cancer radiotherapy
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
This study is testing if spa therapy can help improve skin problems and quality of life for breast cancer survivors who have had radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Association Francaise pour la Recherche Thermale Academic / other |
| Drugs / interventions | Radiation |
| Locations | 13 sites (Bordeaux and 12 other locations) |
| Trial ID | NCT05874492 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have completed postoperative radiotherapy for breast cancer at least six months prior and have moderate to severe skin toxicity.
Not a fit: Patients with progressive or metastatic breast cancer, those undergoing specific treatments for breast cancer, or individuals with bilateral radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for breast cancer survivors suffering from radiation-induced skin fibrosis.
How similar studies have performed: While there is limited research specifically on spa therapy for radiation-induced fibrosis, similar thermal treatments have shown promise in managing chronic skin conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 12 other locations
- 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)
- Institut Paoli-Calmettes — Marseille, France (Recruiting)
- Centre Azuréen de Cancérologie — Mougins, France (Recruiting)
- Centre Eugène Marquis — Rennes, France (Recruiting)
- Centre Hospitalier Roanne — Roanne, France (Recruiting)
- CHU Saint Etienne — Saint-Etienne, France (Recruiting)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (Recruiting)
- Centre François Baclesse — Esch-sur-Alzette, Luxembourg (Not_yet_recruiting)
Study contacts
- Principal investigator: Guillaume Vogin — Centre François Baclesse
- Study coordinator: Nans FUSTIER
- Email: nans.fustier@univ-grenoble-alpes.fr
- Phone: 0476765040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.