Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients
NCT ID: NCT04109326
Last Updated: 2019-09-30
Study Results
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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COMPLETED
NA
360 participants
INTERVENTIONAL
2013-05-15
2016-06-11
Brief Summary
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Detailed Description
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The experimental program will include:
* 8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.
* 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.
The control arm: standard of care
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* The control arm: standard of care
SUPPORTIVE_CARE
NONE
Study Groups
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Adapted Physical Activity and Dietetique
tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment
APAD
8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.
6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.
Control
Standard of care
No interventions assigned to this group
Interventions
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APAD
8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.
6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years old
* Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + 3 taxanes) followed by radiotherapy
* Satisfactory healing from surgical act on breast and lymph nodes
* Ability to understand the nature, goal and study methodology
* Consent to cooperate for clinical assessments
* Affiliation to a social security regime or beneficiary of equivalent social protection
* Written informed consent provided before any study specific procedures
Exclusion Criteria
* Any other primary tumor
* Contra-indication to moderate physical activity: Unchecked high blood pressure; family history of sudden death in a first degree relative; not stabilized heart disease; acute or chronic lung disease resulting in dyspnea for moderate effort; uncontrolled diabetes, carrying a stent; other severe pathologies unstabilized, disabled or not indicated to physical practice.
* Contra-indication to adjuvant chemotherapy or radiotherapy
* Pregnancy or breast feeding (according to the recommendations of the usual adjuvant breast cancer)
* Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
* Legal inability or restricted legal ability
18 Years
FEMALE
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Gilles Romieu
Role: STUDY_CHAIR
Institut du Cancer de Montpellier - Val d'Aurelle
Locations
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Institut Sainte Catherine
Avignon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
CH Ambroise Paré
Marseille, , France
CH Montélimar
Montélimar, , France
ICM
Montpellier, , France
Centre Eugène Marquis
Rennes, , France
Institut de Cancéologie de l'Ouest
Saint-Herblain, , France
Countries
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Other Identifiers
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2012-A01648-35
Identifier Type: REGISTRY
Identifier Source: secondary_id
VA2012/39
Identifier Type: -
Identifier Source: org_study_id