Status:
COMPLETED
Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological fa...
Detailed Description
The experimental arm "APAD": tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment The experimenta...
Eligibility Criteria
Inclusion
- Female patient with histologically proven breast cancer
- 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
- Metastatic disease
- 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
Key Trial Info
Start Date :
May 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2016
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04109326
Start Date
May 15 2013
End Date
June 11 2016
Last Update
September 30 2019
Active Locations (8)
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1
Institut Sainte Catherine
Avignon, France, 84918
2
Centre Oscar Lambret
Lille, France, 59020
3
Centre Léon Bérard
Lyon, France, 69373
4
CH Ambroise Paré
Marseille, France, 13003