NCT01563588

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Centre Jean Perrin · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Metastatic Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	dietaty education, physical training, physiotherapy and SPA cares	12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-10-01
• Completion: 2013-10-01
• First posted: 2012-03-27
• Last updated: 2015-12-28

Locations

2 sites across 1 country: France