Clinical trial NCT01331772: Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
Official title: Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Adequate Physical Condition
Keywords: Breast cancer
Adapted Physical activity
Nutrition
Assessment
Patient education
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Ligue du Rhône
name: Fondation de France
name: Cancéropôle Lyon Auvergne Rhône-Alpes
name: Lions Club Bourg-en-Bresse et Pérouges
name: Association Lyonnaise de Logistique Posthospitalière
name: Ministère de la Recherche
First posted: 2011-04-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance
timeFrame: 6 months
measure: Assessment of acceptability of the intervention and randomization / recruiting capabilities
timeFrame: 6 months
measure: Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions
timeFrame: 12 months
measure: Description of patient satisfaction
timeFrame: Month 12
measure: Medico-economic impact of the intervention
timeFrame: 12 months
measure: Biological study
timeFrame: Day 1 CT, week 9, week 24, month 12
measure: Description of dietary
timeFrame: Day 1 CT, week 24, month 12
measure: Description of level and pattern physical activity
timeFrame: Day 1 CT, Week 9, Week 24, Month 12
measure: Description of anthropometry
timeFrame: Day 1 CT, week 9, week 24, month 12
measure: Description of lipid profiles
timeFrame: Day 1 CT, week 9, week 24, month 12
measure: Assessment of life quality
timeFrame: Day 1 CT, week 24, month 12
measure: Description of anxiety
timeFrame: Day 1 CT, week 24, month 12
measure: Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance
timeFrame: 6 months
measure: Description of body satisfaction
timeFrame: Day 1 CT, week 24, month 12
measure: Description of body composition
timeFrame: Day 1 CT, week 9, week 24, month 12
measure: Description of self-perception
timeFrame: Day 1 CT, week 24, month 12
measure: Description of self esteem
timeFrame: Day 1 CT, week 24, month 12
measure: Description of depression
timeFrame: Day 1 CT, week 24, month 12
Other outcomes:
Locations:
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard
Study officials:
affiliation: Centre Leon Berard
name: Patrick BACHMANN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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