Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Control arm

Dietetic follow up + adapted physical activity

Intervention arm

Patrick BACHMANN, MD

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.

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

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

Rate of patients who completed the full program and analysis of non-compliance grounds during the program

Number of patients contacted by the investigator to participate in the study and rate of patients randomized

Formalization of a program used in real conditions

Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction

Settlement expenses costs, incurred costs and costs avoided by the intervention

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

Collection of patient nutritional intake during 3 days by self-administered questionnaire

Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)

Measurement of weight, height, waist and hip circumference

Measurement of total cholesterol, HDL, LDL and triglycerides

Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)

score calculation of anxiety (STAI questionnaire)

score calculation of QSCPGS questionnaire

Measurement of body composition by impedancemetry

score calculation of self-perception (QSCPGS questionnaire)

score calculation of self-esteem (Rosenzweig scale)

score calculation of depression (BDI questionnaire)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy	NCT01331772	Breast Cancer Adequate Physic...	Control arm Intervention ar...	18 Years - 75 Years	Centre Leon Berard
Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy	NCT01331772	Breast Cancer Adequate Physic...	Control arm Intervention ar...	18 Years - 75 Years	Centre Leon Berard

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