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Brief Title: Spa Therapy for Upper or Lower Limb Lymphoedema
Official Title: Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
Study ID: NCT03580109
Brief Summary: THERMOEDEME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. The aim of this study is to evaluate effects of spa therapy in phlebology with a therapeutic education program in daily life of patients suffering lymphoedema.
Detailed Description: Lymphoedema is a chronic disease related to an insufficiency of the lymphatic system, which most often affects the limbs. Secondary forms are the most common, particularly those following surgical and radiotherapy treatments for cancer, the most classic being the post-therapeutic large arm of breast cancer. The lymphoedema is a traditional phlebology indication in spa therapy. The spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of lymphoedema. The primary endpoint is the comparison of the rate of patients improved from baseline to 6 months on LMS27 (upper limb lymphoedema) or LYMQOL-LEG (lower limb lymphoedema) (Improvement is defined as 7 points between baseline and 6-month follow-up).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cabinet de médecine vasculaire, Albertville, , France
CHU Amiens Picardie, Amiens, , France
Thermes Argelès-Gazost, Argelès-Gazost, , France
Thermes Barbotan Les Bains, Barbotan-les-Thermes, , France
Groupe Hospitalier Mutualiste, Grenoble, , France
Thermes La Léchère, La Léchère, , France
CH Lourdes, Lourdes, , France
Thermes Luz Saint Sauveur, Luz-Saint-Sauveur, , France
Centre Léon Berard, Lyon, , France
CH Tarbes, Tarbes, , France
CHU Toulouse, Toulouse, , France
Clinique générale HPDA, Valence, , France
Clinique du Tonkin, Villeurbanne, , France
Name: Patrick CARPENTIER, MD
Affiliation: Hospital University Grenoble
Role: PRINCIPAL_INVESTIGATOR