Breast Cancer
Conditions
Keywords
chemotherapy, metabolism, weight, body composition
Brief summary
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied. Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.
Interventions
OTHERblood test/ additional measurement
blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation
Sponsors
Centre Jean Perrin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 70 Years
Healthy volunteers
No
Inclusion criteria
* menopausal women * breast cancer * patients requiring chemotherapy treatment * WHO performance status 0-2
Exclusion criteria
* diabetics * patients with metastases * other cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in body composition | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in energy balance | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. | resting energy expenditure, physical activity, food records. |
| Change from baseline in muscle strength | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. | — |
| Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors) | within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later. | — |
Countries
France
Outcome results
None listed