Factors Affecting Weight Gain in Women Receiving Adjuvant Chemotherapy for Breast Cancer
Factors Affecting Weight Gain in Women Receiving Adjuvant Chemotherapy for Breast Cancer
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.

 PROTOCOL OUTLINE:

 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.

 PROJECTED ACCRUAL:

 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