Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer (FIBROTHERME)

Association Francaise pour la Recherche Thermale

Status: Enrolling

Conditions: Breast Cancer; Fibrosis

Treatments: Other: Thermal cure with a primary dermatological indication

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05874492

2023-A00091-44

Details and patient eligibility

About

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.

Full 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).

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Immediate spa treatment

Active Comparator group

Description:

The spa treatment must be carried out within a maximum of 6 weeks after the inclusion visit.

Treatment:

Other: Thermal cure with a primary dermatological indication

Late spa treatment

Sham Comparator group

Description:

The spa treatment must be carried out after the 6-month visit.

Treatment:

Other: Thermal cure with a primary dermatological indication