Non Metastatic Breast Cancer Clinical Trial
Official title:
Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them
are able to find back to their initial weight after all treatments are finished. Other
studies have shown that overweight at diagnosis was associated to a twice higher risk of
relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse.
In western countries, 75% of BCP have insufficient physical activity. Dietary and activity
programs seem to be able to significantly reduce the mortality risk after breast cancer.
The investigators performed a prospective randomized trial consisting in dietary counseling,
physical training and physiotherapy in hydrothermal centers. Intervention were delivered in
small group session lasting 12 days. SPA cares were offered to patients. Patients in the
control group also received dietary counseling given by a dietetician inside anticancer
hospital, and were asked to perform more physical activities. Main endpoints of the trial
addressed quality of life (SF36) one year after inclusion, weight reduction,
anxiety/depression (HAD), sleep quality and long term compliance to instructions. An
economic study was associated to the protocol, for volunteers only.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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