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

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ClinicalTrials.gov Identifier: NCT01563588
Recruitment Status : Terminated (Enrollment lasted longer than expected and expected number of patients could not be matched in time.)
First Posted : March 27, 2012
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Philippe Chollet, Centre Jean Perrin

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non Metastatic Breast Cancer Behavioral: dietaty education, physical training, physiotherapy and SPA cares Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2013

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life (SF36) [ Time Frame: one year after inclusion ]
    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 :
  1. Anxiety/depression scores (HAD) [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ]
    HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.

  2. Weight and morphometric measures [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ]
    Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups

  3. Sleep quality [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ]
    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.

  4. economic figures [ Time Frame: during 2 years after inclusion ]
    health related costs, health insurance costs, social costs


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563588


Locations
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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
More Information
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Additional Information:

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Responsible Party: Philippe Chollet, Professor Yves-Jean Bignon, Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT01563588    
Other Study ID Numbers: PACThe
2008-A 01606 - 49 ( Registry Identifier: AFSSAPS (France) )
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Keywords provided by Philippe Chollet, 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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases