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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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...)

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 12 центров

• 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
• … и ещё 4 центра

Luxembourg · 1 центр

• Centre François Baclesse — Esch-sur-Alzette

Публикации

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Идентификаторы

NCT: NCT05874492 · 2023-A00091-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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