Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer
Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission
Association Francaise pour la Recherche Thermale
110 participants
Jan 29, 2024
INTERVENTIONAL
Conditions
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 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 the end of postoperative radiotherapy for breast cancer.
Eligibility
Inclusion Criteria12
- Female
- Age ≥ 18 years
- In situ or invasive breast cancer
- DLQI ≥ 6 (at least moderate effect on patient's life)
- General status WHO 0-1
- Post-operative radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)
- Unilateral breast radiotherapy
- Skin or soft tissue toxicity (- modules: Skin and subcutaneous tissue disorders / Musculoskeletal disorders / Reproductive organs and breast disorders) 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 Criteria10
- 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
- Obvious skin ulceration in the treated breast
- 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
Interventions
The thermal treatment combines baths which have a sedative, muscle-relaxing effect and encourage joint mobilisation, sprays which have a decongestant effect and, above all, thread-like showers which are carried out by jets of thermal water under high pressure for several minutes plus educational workshops (relaxation, sophrology, hygiene...)
Locations(10)
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NCT05874492