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

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.

Study Overview

• Status: Terminated
• Conditions: Non Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: dietaty education, physical training, physiotherapy and SPA cares

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Puy de Dome
    • Clermont-Ferrand, Puy de Dome, France, 63011
      • Centre Jean Perrin
    • Clermont-Ferrand, Puy de Dome, France, 63100
      • Pole Santé-République

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dietary and physical training; 12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers	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
No Intervention: control; dietary counseling by a dietetician in the anticancer hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (SF36)	Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.	one year after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety/depression scores (HAD)	HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.	inclusion, 6, 12, 18, 24, 36 months
Weight and morphometric measures	Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups	inclusion, 6, 12, 18, 24, 36 months
Sleep quality	6 questions are asked: it rates the delay before sleep onset, the lenght of sleep, the number of awakening, the lenght of wake periods during the night, the concentration/alertness after sleep, and the fatigue in the morning.	inclusion, 6, 12, 18, 24, 36 months
economic figures	health related costs, health insurance costs, social costs	during 2 years after inclusion

Collaborators and Investigators

• Sponsor: Centre Jean Perrin

Publications and helpful links

Helpful Links

• URL to Centre Jean Perrin main page

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 27, 2012

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy; first line treatment; treatments include a chemotherapy; last treatment not performed more than 9 months earlier
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PACThe; 2008-A 01606 - 49 (Registry Identifier: AFSSAPS (France))