Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer

Official title

Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer in Remission

Overview

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.

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).

Interventions

• Other Thermal cure with a primary dermatological indication
  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...)

Primary outcome measures

• Evaluation of the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis after a dermatologically oriented spa treatment. [Time frame: 6 months]

Secondary outcome measures (12)

• Generic quality of life [Time frame: 6 months]
• Cancer quality of life [Time frame: 6 months]
• Senological or Upper Aerodigestive Tract (UADT) Cancer quality of life [Time frame: 6 months]
• Sequelae self assessment [Time frame: 6 months]
• Lesions radiological assessment [Time frame: 6 months]
• Thickness radiological assessment [Time frame: 6 months]
• Volumetric aspect radiological assessment [Time frame: 6 months]
• Consumption of treatment [Time frame: 6 months]
• Consumption of medical consultation [Time frame: 6 months]
• Adverse events [Time frame: 6 months]
• Long-term cure quality of life benefice [Time frame: 12 months]
• Treatment effect size [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• 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
• Radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)
• Unilateral breast radiotherapy for breast cancer patients
• Skin or soft tissue toxicity (- modules: Skin atrophy, fibrosis of deep connective tissues, fibrosis of superficial soft tissues) 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 for breast cancer patients
• Patient with a tracheostomy for patients with head and neck cancer
• Obvious skin ulceration in the site of interest
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

France · 12 centers

• Clinique Tivoli-Ducos — Bordeaux
• Centre Hospitalier Intercommunal Créteil — Créteil
• Institut de Cancérologie de Bourgogne — Dijon
• Centre Hospitalier Universitaire Grenoble Alpes — Grenoble
• Groupe Hospitalier Mutualiste de Grenoble — Grenoble
• Institut Rafael — Levallois-Perret
• Institut Paoli-Calmettes — Marseille
• Centre Azuréen de Cancérologie — Mougins
• … and 4 more centers

Luxembourg · 1 center

• Centre François Baclesse — Esch-sur-Alzette

Publications

• Binder-Foucard F, Bossard N, Delafosse P, Belot A, Woronoff AS, Remontet L; French network of cancer registries (Francim). Cancer incidence and mortality in France over the 1980-2012 period: solid tumors. Rev Epidemiol Sante Publique. 2014 Apr;62(2):95-108. doi: 10.1016/j.respe.2013.11.073. Epub 2014 Mar 7. PMID 24613140
• Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. PMID 16360786
• Mohanti BK, Bansal M. Late sequelae of radiotherapy in adults. Support Care Cancer. 2005 Oct;13(10):775-80. doi: 10.1007/s00520-004-0697-z. Epub 2005 Jul 22. PMID 16041503
• Burnet NG, Johansen J, Turesson I, Nyman J, Peacock JH. Describing patients' normal tissue reactions: concerning the possibility of individualising radiotherapy dose prescriptions based on potential predictive assays of normal tissue radiosensitivity. Steering Committee of the BioMed2 European Union Concerted Action Programme on the Development of Predictive Tests of Normal Tissue Response to Radi PMID 9842969
• Johansson S, Svensson H, Denekamp J. Timescale of evolution of late radiation injury after postoperative radiotherapy of breast cancer patients. Int J Radiat Oncol Biol Phys. 2000 Oct 1;48(3):745-50. doi: 10.1016/s0360-3016(00)00674-x. PMID 11020571
• Sarin R, Dinshaw KA, Shrivastava SK, Sharma V, Deore SM. Therapeutic factors influencing the cosmetic outcome and late complications in the conservative management of early breast cancer. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):285-92. doi: 10.1016/0360-3016(93)90239-r. PMID 8407402
• Safwat A, Bentzen SM, Turesson I, Hendry JH. Deterministic rather than stochastic factors explain most of the variation in the expression of skin telangiectasia after radiotherapy. Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):198-204. doi: 10.1016/s0360-3016(01)02690-6. PMID 11777639
• Foray N, Verrelle P. [DNA repair and repair diseases: between molecular models and clinical reality]. Bull Cancer. 2011 Mar;98(3):257-75. doi: 10.1684/bdc.2011.1326. French. PMID 21454154

Identifiers

NCT: NCT05874492 · 2023-A00091-44

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗