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Clinical Trial Summary

The lymphoedema is a chronic disease caused by an insufficiency of lymphatic system. In France, 100 000 persons are disabled by this disease.

The most classic form is the "swollen arm" which affects the women after surgery and radiotherapy treatments in 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 arm lymphoedema post breast cancer treatments.


Clinical Trial Description

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 post breast cancer treatments.

According to the protocol submitted to authorities in the absence of evidence data on the subject, the protocol plans to verify the frequency of success (improvement of LMS27 by 7 points) after inclusion and follow-up at 6 months of the first 30 patients in order to reassess the number of subjects required, if the initial hypothesis were too far from reality.

The replacement of the missing values will be done for each dimension, for the patients who answered more than half of the questions, by the average of their answers to the other questions of the dimension. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03580109
Study type Interventional
Source Association Francaise pour la Recherche Thermale
Contact Claire EYCHENNE
Phone 334 76 76 50 40
Email claire.eychenne@univ-grenoble-alpes.fr
Status Not yet recruiting
Phase N/A
Start date March 2019
Completion date December 2022

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