Clinical trial NCT05874492: Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibrosis
Breast Cancer
Keywords: fibrosis
breast cancer
radiotherapy
spa treatment
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: Floralis
First posted: 2023-05-25
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups:

* Immediate spa therapy: the patient carries out the spa therapy soon after the enrolment in the study
* Late spa therapy: the patient carries out the spa therapy after the 6-month follow up visit
Primary purpose: OTHER

Brief 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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 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
* 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

Primary outcomes:
measure: Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Generic quality of life
timeFrame: 6 months
measure: Breast Cancer quality of life
timeFrame: 6 months
measure: Senological quality of life
timeFrame: 6 months
measure: Sequelae self assessment
timeFrame: 6 months
measure: Lesions radiological assessment
timeFrame: 6 months
measure: Thickness radiological assessment
timeFrame: 6 months
measure: Volumetric aspect radiological assessment
timeFrame: 6 months
measure: Consumption of treatment
timeFrame: 6 months
measure: Consumption of medical consultation
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
measure: Long-term cure quality of life benefice
timeFrame: 12 months
measure: Treatment effect size
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Dijon
country: France
facility: Institut de Cancérologie de Bourgogne
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Levallois Perret
country: France
facility: Institut Rafael
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Roanne
country: France
facility: Centre Hospitalier Roanne
city: Saint Etienne
country: France
facility: CHU Saint Etienne
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Esch-sur-Alzette
country: Luxembourg
facility: Centre François Baclesse
Study officials:
affiliation: Centre François Baclesse
name: Guillaume Vogin
role: PRINCIPAL_INVESTIGATOR
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