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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-07-31

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.

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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.

Conditions

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Breast Cancer Adequate Physical Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Control arm

Dietetic follow-up only

Group Type OTHER

Control arm

Intervention Type OTHER

Dietetic follow-up only

Intervention arm

Dietetic + adapted physical activity

Group Type EXPERIMENTAL

Intervention arm

Intervention Type OTHER

Dietetic follow up + adapted physical activity

Interventions

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Control arm

Dietetic follow-up only

Intervention Type OTHER

Intervention arm

Dietetic follow up + adapted physical activity

Intervention Type OTHER

Other Intervention Names

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APA arm

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No