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临床试验/NCT00892515
NCT00892515已完成不适用

Women In Steady Exercise Research (WISER) Sister

Abramson Cancer Center at Penn Medicine2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
2
主要终点
Change in the area under the curve for urinary estrogen (E1G-AUC) adjusted for cycle length

研究概览

简要总结

RATIONALE: Exercise may change the risk of developing breast cancer. It is not yet known whether low-intensity exercise or high-intensity exercise is more effective in lowering the risk of breast cancer.

PURPOSE: This randomized clinical trial is studying how well exercise programs work in healthy young women at increased risk of developing breast cancer.

详细描述

OBJECTIVES:

Primary

  • To conduct a dose response study of low- or high-dose exercise over 5 menstrual cycles, with no concomitant dietary changes producing a caloric deficit, in healthy younger women with ≥ 18% lifetime risk for developing breast cancer.
  • To determine the effects of this exercise regimen on variables known to be associated with breast mitotic activity in these participants.

Secondary

  • To assess changes in other physiologic parameters associated with breast mitotic activity (i.e., urinary progesterone [pregnanediol-glucuronide, PdG] from daily first morning urine samples; follicular phase circulating [serum] levels of estradiol, progesterone, testosterone, and prolactin; follicular phase breast density [fibroglandular tissue volume] from magnetic resonance imaging; estrogen metabolites [estrone, estradiol, estriol, 2-OHE_1, 2-OHE_2, 4-OHE_1, 4-OHE_2, 16-OHE_1 and ratios]; adipokines [i.e., adiponectin and Leptin]; and body composition [i.e., % body fat, lean mass, fat mass, total mass]) in these participants.
  • To assess the extent to which changes in body composition and/or body mass mediate observed changes in these participants.
  • To quantify the relationship between estrogen and progesterone from daily urinary measurements with observed menstrual cycle alterations such as follicular and luteal phase length changes, and ovulatory status in these participants.
  • To compare levels and exercise-induced changes in urinary estrogens, estrogen metabolites, circulating hormones, adipokines, and body size across two groups of women who differ as to breast cancer risk in an exploratory manner.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
Single

入排标准

年龄范围
18 Years 至 35 Years(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

结局指标

主要结局

Change in the area under the curve for urinary estrogen (E1G-AUC) adjusted for cycle length

次要结局

  • Extent to which changes in body composition and body mass mediate observed changes in E1G-AUC
  • Effects of exercise on variables known to affect or reflect mitogenic activity as related to breast cancer risk
  • Relationship between estrogen and progesterone from daily urinary measurements with observed menstrual cycle alterations (i.e., follicular and luteal phase length changes, and ovulatory status)
  • Changes in other physiologic parameters associated with breast mitotic activity

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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