Status:
UNKNOWN
Spa Therapy for Upper or Lower Limb Lymphoedema
Lead Sponsor:
Association Francaise pour la Recherche Thermale
Collaborating Sponsors:
Floralis
Conditions:
Lymphoedema
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion Criteria:
- 18 years old and older
- available for a spa treatment (phlebology indication) during 18 days and a follow up period of 15 months
- with permanent lymphoedema of the upper or lower limb (2 ou 3 stade of International Society for Lymphology scale)
- voluntary to participate to the study, informed consent form signed after appropriate information
- affiliation to the social security system or equivalent
Exclusion Criteria:
- cancer undergoing chemotherapy and radiotherapy treatment in primary phase
- the baseline score of LMS27 or LYMQOL-LEG > 79
- pain of upper limb linked with a radical plexitis
- contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
- Erysipelas case history in the last 6 months or pachyderma and lymphangiectasia
- no previous spa treatment for upper limb lymphoedema during the spa year
- risk of intensive treatment in the next 6 months
- subject participating to an other clinical study interventional
- pregnancy, parturient or breast feeding
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03580109
Start Date
June 20 2019
End Date
December 1 2025
Last Update
March 6 2024
Active Locations (13)
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1
Cabinet de médecine vasculaire
Albertville, France, 73200
2
CHU Amiens Picardie
Amiens, France, 80054
3
Thermes Argelès-Gazost
Argelès-Gazost, France, 65400
4
Thermes Barbotan Les Bains
Barbotan-les-Thermes, France, 32150