Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Centre Leon Berard
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control arm
Dietetic follow-up only
Intervention: Control arm (Other)
Intervention arm
Dietetic + adapted physical activity
Intervention: Intervention arm (Other)
Outcomes
Primary Outcomes
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
Time Frame: 6 months
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
Secondary Outcomes
- Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions(12 months)
- Description of body satisfaction(Day 1 CT, week 24, month 12)
- Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance(6 months)
- Assessment of acceptability of the intervention and randomization / recruiting capabilities(6 months)
- Description of level and pattern physical activity(Day 1 CT, Week 9, Week 24, Month 12)
- Description of lipid profiles(Day 1 CT, week 9, week 24, month 12)
- Description of anxiety(Day 1 CT, week 24, month 12)
- Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance(6 months)
- Description of patient satisfaction(Month 12)
- Biological study(Day 1 CT, week 9, week 24, month 12)
- Description of body composition(Day 1 CT, week 9, week 24, month 12)
- Description of depression(Day 1 CT, week 24, month 12)
- Medico-economic impact of the intervention(12 months)
- Assessment of life quality(Day 1 CT, week 24, month 12)
- Description of self esteem(Day 1 CT, week 24, month 12)
- Description of dietary(Day 1 CT, week 24, month 12)
- Description of anthropometry(Day 1 CT, week 9, week 24, month 12)
- Description of self-perception(Day 1 CT, week 24, month 12)