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

NCT ID: NCT01563588

Last Updated: 2015-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Metastatic Breast Cancer

Keywords

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breast cancer chemotherapy first line treatment treatments include a chemotherapy last treatment not performed more than 9 months earlier

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

dietaty education, physical training, physiotherapy and SPA cares

Intervention Type BEHAVIORAL

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

control

dietary counseling by a dietetician in the anticancer hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Philippe Chollet

Professor Yves-Jean Bignon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre Jean Perrin

Clermont-Ferrand, Puy de Dome, France

Site Status

Pole Santé-République

Clermont-Ferrand, Puy de Dome, France

Site Status

Countries

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France

Related Links

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http://www.cjp.fr/

URL to Centre Jean Perrin main page

Other Identifiers

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2008-A 01606 - 49

Identifier Type: REGISTRY

Identifier Source: secondary_id

PACThe

Identifier Type: -

Identifier Source: org_study_id