Clinical trial NCT04109326: Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients
Official title: Effect of a Tailored Program of Physical Activity and Nutritional Therapeutic Education on Clinical, Psychological and Sociological Factors in Breast Cancer Patients Undergoing Adjuvant Treatment : Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Physical activity
Nutrition
Therapeutic education
Breast cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 control arm: standard of care
Primary purpose: SUPPORTIVE_CARE

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 factors in breast cancer patients undergoing adjuvant treatment.

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 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

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Rate of cancer-related fatigue
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: CH Ambroise Paré
city: Montpellier
country: France
facility: ICM
city: Montélimar
country: France
facility: CH Montélimar
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Herblain
country: France
facility: Institut de Cancéologie de l'Ouest
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Gilles Romieu
role: STUDY_CHAIR
References: