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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

18 Years
75 Years
Open (Enrolling)
Breast Cancer, Adequate Physical Condition

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Trial Information

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

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

- 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

- Deprived of their liberty by court or administrative decision,

- Pregnant or nursing, of childbearing age without effective contraception during the

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome 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

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

July 2011

Completion Date:

July 2014

Related Keywords:

  • Breast Cancer
  • Adequate Physical Condition
  • Breast cancer
  • Adapted Physical activity
  • Nutrition
  • Assessment
  • Patient education
  • Breast Neoplasms
  • Food Habits