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

Centre Jean Perrin

Status: Terminated

Conditions: Non Metastatic Breast Cancer

Treatments: Behavioral: dietaty education, physical training, physiotherapy and SPA cares

Study type: Interventional

Funder types: Other

Identifiers

NCT01563588

PACThe

2008-A 01606 - 49 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• breast cancer
• treatment including a chemotherapy
• in complete remission
• last treatment in the last 9 months before inclusion
• signed consent

Exclusion criteria

• metastatic disease
• relapse
• women enable to have physical activity
• heart disease or any pathology preventing physical activity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

dietary and physical training

Experimental group

Description:

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

Treatment:

Behavioral: dietaty education, physical training, physiotherapy and SPA cares

control

No Intervention group

Description:

dietary counseling by a dietetician in the anticancer hospital