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.
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
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
Parallel
Thermal cure with a primary dermatological indication
Other interventionThe 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...)
Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment.
Self-assessment by the patient of the dermatological quality of life by the DLQI (Dermatology Life Quality Index) score at 6 months after the end of the treatment compared between the intervention group (immediate treatment) and the control group (delayed treatment after 6 months). The DLQI score is between 0 and 30 where a high score indicates a significant impairment of quality of life.
Generic quality of life
Evaluation of the medical benefit on generic quality of life. Patient self-assessment of generic quality of life using the EQ5D-3L. EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ5D has 6 items intended to measure general health. The index score is between -0.53 and 1 where a high value indicates a good quality of life. The perceived health status is between 0 and 100 where a high value indicates good health.
Cancer quality of life
Evaluation of the medical benefit on quality of life in patients with breast cancer or Upper Aerodigestive Tract (UADT) Cancer. Patient self-assessment of quality of life using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ C30 Score (Quality of Life of Cancer Patients). The EORTC QLQ-C30 has 15 domains. There is no total score. For each domain, the score is between 0 and 100 where a high score for overall health and functional dimensions represents a good quality of life; and a high score for symptomatic dimensions represents a high level of symptoms.
Senological or Upper Aerodigestive Tract (UADT) Cancer quality of life
Evaluation of the medical benefit on the quality of senological life or Upper Aerodigestive Tract (UADT) Cancer. Patient self-assessment of breast quality of life using the specific QLQ-BR23 module (breast cancer-specific quality of life questionnaire). Patient self-assessment of Upper Aerodigestive Tract (UADT) Cancer quality of life using the specific QLQ-H\&N43 module (Quality of life in patients with head and neck cancer).
Sequelae self assessment
Evaluation of the medical benefit on the self-assessment of the impact of radio induced sequelae. Self-assessment by the patient with an evaluation of the severity of the radiation-induced sequelae via the Pro-CTCAE self-questionnaire (Item 1: dry mouth, Item 2: difficulty swallowing, Item 3: mouth/throat sores, Item 4: cracked corners of the mouth, Item 5: changes in voice quality, Item 6: hoarseness, Item 7: changes in taste (Items 1-7 specific to head and neck cancer), item 25: skin dryness, item 28: itching, item 36: skin reaction to radiation, item 37: skin darkening, item 48: general pain, item 53: fatigue, item 54: anxiety, item 56: sadness, item 72: breast swelling and tenderness (item 72 specific to breast cancer)).
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Association Francaise pour la Recherche Thermale
Lead sponsor
Floralis
Collaborator