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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
60
Dietetic follow-up only
Dietetic follow up + adapted physical activity
Centre Leon Berard
Lyon, France
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
Time frame: 6 months
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
Time frame: 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
Time frame: 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
Time frame: 12 months
Description of patient satisfaction
Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction
Time frame: Month 12
Medico-economic impact of the intervention
Settlement expenses costs, incurred costs and costs avoided by the intervention
Time frame: 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
Time frame: Day 1 CT, week 9, week 24, month 12
Description of dietary
Collection of patient nutritional intake during 3 days by self-administered questionnaire
Time frame: 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)
Time frame: Day 1 CT, Week 9, Week 24, Month 12
Description of anthropometry
Measurement of weight, height, waist and hip circumference
Time frame: Day 1 CT, week 9, week 24, month 12
Description of lipid profiles
Measurement of total cholesterol, HDL, LDL and triglycerides
Time frame: Day 1 CT, week 9, week 24, month 12
Assessment of life quality
Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)
Time frame: Day 1 CT, week 24, month 12
Description of anxiety
score calculation of anxiety (STAI questionnaire)
Time frame: 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
Time frame: 6 months
Description of body satisfaction
score calculation of QSCPGS questionnaire
Time frame: Day 1 CT, week 24, month 12
Description of body composition
Measurement of body composition by impedancemetry
Time frame: Day 1 CT, week 9, week 24, month 12
Description of self-perception
score calculation of self-perception (QSCPGS questionnaire)
Time frame: Day 1 CT, week 24, month 12
Description of self esteem
score calculation of self-esteem (Rosenzweig scale)
Time frame: Day 1 CT, week 24, month 12
Description of depression
score calculation of depression (BDI questionnaire)
Time frame: Day 1 CT, week 24, month 12
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