Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients (APAD2)

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Completed

Conditions: Breast Cancer

Treatments: Other: APAD

Study type: Interventional

Funder types: Other

Identifiers

NCT04109326

VA2012/39

2012-A01648-35 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 360 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Adapted Physical Activity and Dietetique

Experimental group

Description:

tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment

Treatment:

Other: APAD

Control

No Intervention group

Description:

Standard of care