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.
Radiation-induced fibrosis is an equivalent of an "orphan disease", in which oncologists have only recently shown interest, despite its prevalence. No study on the medical service provided by crenotherapy has been published in late radiation-induced fibrosis, which shares a common pathophysiology and medico-psycho-social sequelae with the sequelae of burns. Chronic progressive dermatoses are part of the 12 main therapeutic orientations of medical thermalism. In particular, burn scars are a very current indication. Crenotherapy allows the attenuation, or even the disappearance of: pruritus and dysesthesia, local inflammation, hypertrophy and sclerosis and favours the recovery of chronic superficial erosions. Fibrous scars, even old ones, respond favourably to thermal treatments. The thermal treatment combines baths which have a sedative, muscle-relaxing effect and which favour 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. The primary endpoint is the self-assessment by the patient of the dermatological quality of life by the DLQI 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
110
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...)
Clinique Tivoli-Ducos
Bordeaux, France
RECRUITINGCentre Hospitalier Intercommunal Créteil
Créteil, France
RECRUITINGInstitut de Cancérologie de Bourgogne
Dijon, France
RECRUITINGCentre Hospitalier Universitaire Grenoble Alpes
Grenoble, France
RECRUITINGGroupe Hospitalier Mutualiste de Grenoble
Grenoble, France
RECRUITINGInstitut Rafael
Levallois-Perret, France
RECRUITINGInstitut Paoli-Calmettes
Marseille, France
RECRUITINGCentre Azuréen de Cancérologie
Mougins, France
RECRUITINGCentre Eugène Marquis
Rennes, France
RECRUITINGCentre Hospitalier Roanne
Roanne, France
RECRUITING...and 3 more locations
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
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)).
Time frame: 6 months
Lesions radiological assessment
Hetero-evaluation of the clinical and imaging efficacy of treatment on post-radiation lesions with CTCAE scale (Common Terminology Criteria for Adverse Events). There is no total score. For each domain, the rank is between 1 and 5 where a high score represents the death.
Time frame: 6 months
Thickness radiological assessment
Hetero-evaluation of the clinical and imaging efficacy of treatment on post-radiation lesions of thickness. Imaging assessment with blinded measurement by an independent radiologist of comparative thickness by ultrasound: Dermal radiotoxicity for breast cancer can indeed be defined as the difference in dermal thickness between the 2 breasts (lesion area and mirror area of the contralateral breast). Cutaneous radiotoxicity in head and neck cancers will be assessed by comparing irradiated areas with unexposed control areas. Dermal thickness is defined as the distance between the input ultrasound signal and the signal at the dermal-hypodermal interface at 6 months.
Time frame: 6 months
Volumetric aspect radiological assessment
Hetero-evaluation of the clinical and imaging efficacy of treatment on post-radiation lesions with HBCS (Harvard-Breast-Cosmesis-Scale). Evaluation of the cutaneous and volumetric aspect by an evaluation carried out by the practitioner with the Harvard-breast-cosmesis-scale (HBCS) score at 6 months. The HBCS score is assessed by a 4-point Likert scale where a high value indicates a high severity, 1 represents excellent breast shape or texture, 2 means good, 3 average and 4 poor with a severely deformed breast.
Time frame: 6 months
Consumption of treatment
Comparison of the type of treatment between the 2 groups.
Time frame: 6 months
Consumption of medical consultation
Comparison of the number of hospitalisations, consultations, physiotherapy, specific cosmetic consultations between the 2 groups.
Time frame: 6 months
Adverse events
Comparison of the adverse events in the 2 groups. Description of adverse events between the 2 groups.
Time frame: 6 months
Long-term cure quality of life benefice
Evaluation of the stability of the long-term effect for the immediate cure group. Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes. Self-assessment by the patient of the dermatological quality of life by the DLQI (Dermatology Life Quality Index).
Time frame: 12 months
Treatment effect size
Evaluation of the effect size of the treatment for the delayed treatment group. Confirmation of the size of the effect of the treatment on the primary and main secondary endpoints between 6 and 12 months.
Time frame: 12 months
Subgroup analysis of the primary outcome
Stratification based on the location of the treated site (following breast cancer or cancer of the upper aerodigestive tract). Stratification by center to test for a center effect.
Time frame: 6 months
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