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

This study has been terminated.
(Enrollment lasted longer than expected and expected number of patients could not be matched in time.)
Sponsor:
Collaborator:
AFRETH - French association for hydrothermal research
Information provided by (Responsible Party):
Philippe Chollet, Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT01563588
First received: February 22, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Non Metastatic Breast Cancer
Behavioral: dietaty education, physical training, physiotherapy and SPA cares

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • Quality of life (SF36) [ Time Frame: one year after inclusion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Anxiety/depression scores (HAD) [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ] [ Designated as safety issue: No ]
    HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.

  • Weight and morphometric measures [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ] [ Designated as safety issue: No ]
    Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups

  • Sleep quality [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ] [ Designated as safety issue: No ]
    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.

  • economic figures [ Time Frame: during 2 years after inclusion ] [ Designated as safety issue: No ]
    health related costs, health insurance costs, social costs


Enrollment: 251
Study Start Date: May 2008
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563588

Locations
France
Centre Jean Perrin
Clermont-Ferrand, Puy de Dome, France, 63011
Pole Santé-République
Clermont-Ferrand, Puy de Dome, France, 63100
Sponsors and Collaborators
Centre Jean Perrin
AFRETH - French association for hydrothermal research
  More Information

Additional Information:
No publications provided

Responsible Party: Philippe Chollet, Professor Yves-Jean Bignon, Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01563588     History of Changes
Other Study ID Numbers: PACThe, 2008-A 01606 - 49
Study First Received: February 22, 2012
Last Updated: March 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Jean Perrin:
breast cancer
chemotherapy
first line treatment
treatments include a chemotherapy
last treatment not performed more than 9 months earlier

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014