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Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission (NCT02898376)

Association Francaise pour la Recherche Thermale
This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.
  • Other: skin-oriented spa care
    standardized procedure : 72 care sessions over 18 days of treatment +/- Additional care according to the specificity of each spa
    • Drug: Pentoxifylline
      400 mg bid during at least 6 months
      • Drug: Tocopherol acetate
        500 mg bid during at least 6 months
        Ages eligible for Study
        18 Years to 80 Years
        Genders eligible for Study
        Female
        Accepts Healthy Volunteers
        No
        Inclusion Criteria:
        • women
        • age ≥ 18 and <80 years old
        • invasive or in situ breast carcinoma
        • non-metastatic disease.
        • postoperative radiotherapy completed since at least 6 months
        • unilateral breast radiotherapy
        • grade > 2 dermal and/or soft tissue toxicity (CTCAE v4.0)
        • no inflammatory ou infectious flare on the breast at the time of inclusion
        • ability to provide an informed written consent form
        • affiliation to a social security system
        Exclusion Criteria:
        • age <18 or ≥ 80 years old
        • evolutive cancer
        • Metastatic Disease
        • Patient undergoing specific treatment for breast cancer (except adjuvant endocrine therapy and / or adjuvant Herceptin) at the time of inclusion
        • bilateral Breast/chest wall Radiotherapy
        • breast prosthesis bearer
        • Body Mass Index > 40 or <18.5
        • chronic skin ulceration within the treated breast at the time of inclusion
        • contraindications to spa care :
        • inflammatory disease in flare at the time of inclusion
        • active infections
        • heart failure (NYHA class> 1)
        • chronic respiratory failure
        • labile blood pressure
        • bullous dermatitis
        • evolutive chronic skin disease
        • hypersensitivity to pentoxifylline or any of the excipients
        • acute myocardial infarction
        • ongoing hemorrhage or major bleeding risk
        • use of oral anticoagulants
        • pregnant or likely to be in 6 months or breastfeeding
        • patients deprived of liberty or under supervision
        The combination of PTX and vit E appears as the standard treatment of radiation induced fibrosis. Synergism between PTX and Vit E is likely, as treatment with each drug alone is ineffective. This combination was also positively evaluated in the treatment of osteoradionecrosis, radiation-induced pelvic neuropathies, pneumoniae as well as bowel pathologies.

        Spa cares are part of the standard treatment of burn scars. Two spa treatments per year enable the mitigation or disappearance (after several treatments) of pruritus, dysesthesia, local inflammation, hypertrophy and sclerosis. They promote the healing of chronic superficial erosions. The spa treatment combines baths, sprays and especially filiform showers with thermal water jets under high pressure for a few minutes.

        21 locations

        France (21)
        • CHU de Besançon Hôpital Jean Minjoz
          not yet recruiting
          Besançon, France, 25000
        • ONCODOC
          not yet recruiting
          Béziers, France, 34500
        • Centre d'Oncologie et de Radiothérapie du Parc
          not yet recruiting
          Chalon-sur-Saône, France, 71100
        • Clinique du Parc de Charleville-Mézières
          not yet recruiting
          Charleville-Mézières, France, 08000
        • CLCC Jean Perrin
          not yet recruiting
          Clermont Ferrand, France, 63000
        • Hôpitaux Civils de Colmar
          not yet recruiting
          Colmar, France, 68000
        • Centre Georges-François Leclerc
          not yet recruiting
          Dijon, France, 21079
        • Institut Daniel Hollard
          not yet recruiting
          Grenoble, France, 38000
        • CHU de Grenoble, Hôpital A.Michallon
          not yet recruiting
          La Tronche, France, 38700
        • CHR Metz-Thionville Hôpital de Mercy
          not yet recruiting
          Metz, France
        • CH de Belfort-Montbéliard Site du Mittan
          not yet recruiting
          Montbelliard, France, 25200
        • CH de Mulhouse
          not yet recruiting
          Mulhouse, France, 68100
        • Centre d'Oncologie de Gentilly
          not yet recruiting
          Nancy, France, 54100
        • CHU de Poitiers
          not yet recruiting
          Poitiers, France, 86000
        • Institut Jean Godinot de Reims
          not yet recruiting
          Reims, France, 51100
        • CLCC Saint Etienne
          not yet recruiting
          Saint-Priest en Jarez, France, 42270
        • Centre Paul Strauss
          not yet recruiting
          Strasbourg, France, 67000
        • Clinique de l'Orangerie
          not yet recruiting
          Strasbourg, France, 67000
        • Institut Universitaire du Cancer
          not yet recruiting
          Toulouse, France, 31000
        • CH de Troyes
          not yet recruiting
          Troyes, France, 10000
        • Institut de Cancérologie de Lorraine
          not yet recruiting
          Vandoeuvre-les-Nancy, France, 54519
        Status:
        not yet recruiting
        Type:
        Interventional
        Phase:
        Start:
        31 August, 2017
        Updated:
        26 April, 2017
        Participants:
        142
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