Study Stopped
Enrollment lasted longer than expected and expected number of patients could not be matched in time.
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
2 other identifiers
interventional
251
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedDecember 28, 2015
December 1, 2015
1.8 years
February 22, 2012
December 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Anxiety/depression scores (HAD)
inclusion, 6, 12, 18, 24, 36 months
Weight and morphometric measures
inclusion, 6, 12, 18, 24, 36 months
Sleep quality
inclusion, 6, 12, 18, 24, 36 months
economic figures
during 2 years after inclusion
Study Arms (2)
dietary and physical training
EXPERIMENTAL12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
control
NO INTERVENTIONdietary counseling by a dietetician in the anticancer hospital
Interventions
12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
Eligibility Criteria
You may qualify if:
- breast cancer
- treatment including a chemotherapy
- in complete remission
- signed consent
You may not qualify if:
- metastatic disease
- relapse
- women enable to have physical activity
- heart disease or any pathology preventing physical activity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Jean Perrin
Clermont-Ferrand, Puy de Dome, 63011, France
Pole Santé-République
Clermont-Ferrand, Puy de Dome, 63100, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Yves-Jean Bignon
Study Record Dates
First Submitted
February 22, 2012
First Posted
March 27, 2012
Study Start
December 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2013
Last Updated
December 28, 2015
Record last verified: 2015-12