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Spa Therapy for Upper or Lower Limb Lymphoedema

RECRUITINGN/ASponsored by Association Francaise pour la Recherche Thermale
Actively Recruiting
PhaseN/A
SponsorAssociation Francaise pour la Recherche Thermale
Started2019-06-20
Est. completion2024-12
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions7

Breast CancerCancerGynaecological CancerLymphoedemaLymphomaMalignant DiseaseProstate Cancer

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