Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

Study Overview
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Brief Summary
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Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue. After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program. Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

Detailed Description
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With approximately 52,600 new cases diagnosed in France in 2010, breast cancer is the most common cancer in women, according to national projections of the incidence and cancer mortality for 2010. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Several hypotheses explain the association between obesity and breast cancer: obesity, metabolic syndrome and diabetes participate to changes in hormone levels (estrogen, leptin, insulin) that promotes mammary carcinogenesis and tumor progression. The association between obesity and development of breast cancer is partly due to increased serum levels of estradiol produced by adipocytes, but the role of insulin resistance and inflammation associated with obesity is widely discussed. Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Thus, several large cohort studies of women with breast cancer showed an average mortality reduction of 45% associated with moderate physical activity compared with inactivity. Adapted Physical Activity (APA) could also improve fitness, quality of life, body image, treatment compliance and reduce fatigue. A rich fruits and vegetables diet combined with regular physical activity appears to offer the best protection from breast cancer. The nature, frequency, duration, intensity and arrangement of physical training program meetings are key elements to consider, metabolic responses differ according to these factors. The optimal management for an improved level of physical activity appear to be an individual of at least three sessions per week, 30 to 60 minutes each with a moderate intensity, allowing a physiological response to chronic exercise and an adequate recovery. After diagnosis of breast cancer, there is thus many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program. Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

Official Title
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Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

Conditions
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Breast Cancer, Adequate Physical Condition

Intervention / Treatment
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* Other: Control arm
* Other: Intervention arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 18 years ≤ age < 75 years With an invasive, non-metastatic, histologically confirmed, first breast carcinoma Requiring the prescription of a first line of adjuvant chemotherapy Followed in the research center Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician, the referring physician or the physician investigator Residing within a radius of 60 km around the center investigator or agreeing to bear the travel costs beyond proposed reimbursement Availability and willingness to invest in the PASAPAS study during the program (6 months) and during the post-program follow-up (6 months) Able to understand, read and write French Covered by a medical insurance Written, signed informed consent Exclusion Criteria: Female with metastatic or inflammatory breast cancer, History or concomitant primary cancer (except for carcinoma in situ of the uterine cervix and/or skin basal cell carcinoma and or colon carcinoma in situ and/or not a breast cancer in complete response for at least 5 years) Cons-indication to physical activity practice, at discretion of the investigator, In a state of severe malnutrition according to the criteria of the High Authority for Health (HAS) 2010, namely: Among women ≤ 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month Among women > 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month, body mass index < 18 kg / m² History of eating disorders, Not possible follow-up for medical, social, familial, geographical or psychological reasons, during the program (6 months) and during the post-program follow-up (6 months), Deprived of their liberty by court or administrative decision, Pregnant or nursing, of childbearing age without effective contraception during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm<br>Dietetic follow-up only | Other: Control arm<br>* Dietetic follow-up only<br>|
| Experimental: Intervention arm<br>Dietetic + adapted physical activity | Other: Intervention arm<br>* Dietetic follow up + adapted physical activity<br>* Other names: APA arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment in a cohort of adult patients with a 1st breast cancer non-metastatic, the feasibility of implementing an APA intervention during 6 months, in addition to a dietary management, concomitant to prescription of a first-line adjuvant chemotherapy | Proportion of patients who participate in at least two mandatory APA sessions by week during all the APA program, except during the 1st week of each course of CT | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance | Rate of patients who completed the full program and analysis of non-compliance grounds during the program | 6 months | 
| Assessment of acceptability of the intervention and randomization / recruiting capabilities | Number of patients contacted by the investigator to participate in the study and rate of patients randomized | 6 months | 
| Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions | Formalization of a program used in real conditions | 12 months | 
| Description of patient satisfaction | Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction | Month 12 | 
| Medico-economic impact of the intervention | Settlement expenses costs, incurred costs and costs avoided by the intervention | 12 months | 
| Biological study | Analyses of metabolomic profiles and adipokines expression linked to breast cancer at initial diagnosis (before surgery) and description of metabolism changes during nutritional interventions and therapeutic care | Day 1 CT, week 9, week 24, month 12 | 
| Description of dietary | Collection of patient nutritional intake during 3 days by self-administered questionnaire | Day 1 CT, week 24, month 12 | 
| Description of level and pattern physical activity | Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire) | Day 1 CT, Week 9, Week 24, Month 12 | 
| Description of anthropometry | Measurement of weight, height, waist and hip circumference | Day 1 CT, week 9, week 24, month 12 | 
| Description of lipid profiles | Measurement of total cholesterol, HDL, LDL and triglycerides | Day 1 CT, week 9, week 24, month 12 | 
| Assessment of life quality | Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36) | Day 1 CT, week 24, month 12 | 
| Description of anxiety | score calculation of anxiety (STAI questionnaire) | Day 1 CT, week 24, month 12 | 
| Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance | Rate of patients who completed the full program and analysis of non-compliance grounds during the program | 6 months | 
| Description of body satisfaction | score calculation of QSCPGS questionnaire | Day 1 CT, week 24, month 12 | 
| Description of body composition | Measurement of body composition by impedancemetry | Day 1 CT, week 9, week 24, month 12 | 
| Description of self-perception | score calculation of self-perception (QSCPGS questionnaire) | Day 1 CT, week 24, month 12 | 
| Description of self esteem | score calculation of self-esteem (Rosenzweig scale) | Day 1 CT, week 24, month 12 | 
| Description of depression | score calculation of depression (BDI questionnaire) | Day 1 CT, week 24, month 12 | 

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