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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: APAD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted Physical Activity and Dietetique<br>tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment | Other: APAD<br>* 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.<br>|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cancer-related fatigue | The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Nutrition, Therapeutic education, Breast cancer