Phase
Condition
Breast Cancer
Cancer
Scar Tissue
Treatment
Thermal cure with a primary dermatological indication
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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 postradiotherapy delay)
Unilateral breast radiotherapy
Skin or soft tissue toxicity (- modules: Skin and subcutaneous tissue disorders /Musculoskeletal disorders / Reproductive organs and breast disorders) CTCAE v4.0grade ≥ 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
Exclusion Criteria:
Progressive phase of cancer
Metastatic disease
Patient undergoing specific treatment for breast cancer (except adjuvant hormonetherapy 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 arebreastfeeding
Persons deprived of liberty or under guardianship
Study Design
Study Description
Connect with a study center
Clinique Tivoli-Ducos
Bordeaux, 33000
FranceActive - Recruiting
Institut de Cancérologie de Bourgogne
Dijon, 21000
FranceActive - Recruiting
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38000
FranceActive - Recruiting
Centre de cancérologie de la Sarthe
Le Mans, 72000
FranceSite Not Available
Institut Rafael
Levallois Perret,
FranceActive - Recruiting
Centre Léon Bérard
Lyon, 69973
FranceSite Not Available
Centre Azuréen de Cancérologie
Mougins,
FranceActive - Recruiting
Centre Eugène Marquis
Rennes, 35000
FranceActive - Recruiting
Centre Hospitalier Roanne
Roanne,
FranceActive - Recruiting
CHU Saint Etienne
Saint Etienne,
FranceActive - Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
FranceActive - Recruiting
Centre François Baclesse
Esch-sur-Alzette, L-4240
LuxembourgSite Not Available
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