RATIONALE: Chemotherapy may affect various factors that can lead to weight gain.
PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving
adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.
OBJECTIVES: I. Evaluate the relative contributions of factors that may lead to weight gain
in breast cancer patients receiving adjuvant chemotherapy. Factors examined include:
Hormonal and growth factor status (follicle stimulating hormone, total, bound, and free
estradiol, androgens, sex hormone binding globulin, thyroid hormones, prolactin,
insulin-like growth factors I and II, and plasma leptin) Factors affecting energy intake or
expenditure (oral intake, physical activity, and resting metabolic rate) Psychological
factors (depression and quality of life) II. Evaluate the effect of chemotherapy on
hormonal and growth factor status in these patients.
III. Assess the impact of chemotherapy on bone marrow density in these patients.
Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits):
(i) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day
hospital 1 week apart); (ii) 2-3 weeks after chemotherapy has ended (2 visits, 1 week
apart); and (iii) 6 months after chemotherapy has ended (1 visit). Tests conducted during
these visits include evaluation of blood for hormones, growth factors, and leptin; body
composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan;
and evaluation of resting metabolic rate and daily energy expenditure by a single
administration of doubly labeled water at visits "a" and "b" during data collection
timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer,
dietary intake, physical activity, depression, and quality of life are also administered at
the three timepoints.
A total of 140 patients will be accrued for this study within 1-2 years.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically proven newly diagnosed stage I, II, or
resectable IIIA primary breast cancer Scheduled to receive chemotherapy No distant
metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: See
Disease Characteristics No concurrent neoadjuvant chemotherapy Endocrine therapy: No
concurrent thyroid medication Radiotherapy: No concurrent radiotherapy Surgery: See
Disease Characteristics No prior oophorectomy Other: No concurrent alternative medicines
alone No concurrent participation in dietary and/or exercise weight loss programs
--Patient Characteristics-- Age: 18 to 80 Sex: Female Menopausal status: Premenopausal or
postmenopausal Performance status: Not specified Life expectancy: Not specified
Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No
physical or mental disability that would preclude completing questionnaires No prior or
concurrent diabetes mellitus No prior hypothyroidism or hyperthyroidism