Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer
NCT ID: NCT05874492
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2024-01-29
2026-04-30
Brief Summary
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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
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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
OTHER
SINGLE
Study Groups
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Immediate spa treatment
The spa treatment must be carried out within a maximum of 6 weeks after the inclusion visit.
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...)
Late spa treatment
The spa treatment must be carried out after the 6-month visit.
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...)
Interventions
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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...)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Floralis
INDUSTRY
Association Francaise pour la Recherche Thermale
OTHER
Responsible Party
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Principal Investigators
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Guillaume Vogin
Role: PRINCIPAL_INVESTIGATOR
Centre François Baclesse
Locations
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Clinique Tivoli-Ducos
Bordeaux, , France
Institut de Cancérologie de Bourgogne
Dijon, , France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, , France
Institut Rafael
Levallois-Perret, , France
Centre Azuréen de Cancérologie
Mougins, , France
Centre Eugène Marquis
Rennes, , France
Centre Hospitalier Roanne
Roanne, , France
CHU Saint Etienne
Saint-Etienne, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Centre François Baclesse
Esch-sur-Alzette, , Luxembourg
Countries
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Central Contacts
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Facility Contacts
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Christophe Debelleix
Role: primary
Benjamin Schipman
Role: primary
Marie-Virginie Claeys
Role: primary
Alain TOLEDANO
Role: primary
Alexander FALK
Role: primary
Mohamed Benchalal
Role: primary
Amel BLANCHARD
Role: primary
Aurélie BENETON
Role: primary
Selima Sellami
Role: primary
Guillaume Vogin
Role: primary
References
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Offersen BV, Alsner J, Nielsen HM, Jakobsen EH, Nielsen MH, Krause M, Stenbygaard L, Mjaaland I, Schreiber A, Kasti UM, Overgaard J; Danish Breast Cancer Group Radiation Therapy Committee. Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial. J Clin Oncol. 2020 Nov 1;38(31):3615-3625. doi: 10.1200/JCO.20.01363. Epub 2020 Sep 10.
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Hardy P. [Crenotherapy applied to scarring due to burns]. Ann Chir Plast. 1968 Jun;13(2):151-6. No abstract available. French.
Kwiatkowski F, Mouret-Reynier MA, Duclos M, Leger-Enreille A, Bridon F, Hahn T, Van Praagh-Doreau I, Travade A, Gironde M, Bezy O, Lecadet J, Vasson MP, Jouvency S, Cardinaud S, Roques CF, Bignon YJ. Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the 'Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts' (PACThe) randomised clinical trial of 251 patients. Eur J Cancer. 2013 May;49(7):1530-8. doi: 10.1016/j.ejca.2012.12.021. Epub 2013 Jan 24.
Related Links
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Rapport 2013 de l'Observatoire sociétal des cancers. 2014.
Other Identifiers
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2023-A00091-44
Identifier Type: -
Identifier Source: org_study_id