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临床试验/NCT00019643
NCT00019643终止不适用

Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 1999年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
1

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

研究点 (1)

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