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Spots Global Cancer Trial Database for Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy

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Trial Identification

Brief Title: Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy

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

Study ID: NCT01563588

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Centre Jean Perrin, Clermont-Ferrand, Puy de Dome, France

Pole Santé-République, Clermont-Ferrand, Puy de Dome, France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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