跳至主要内容
临床试验/NCT00892515
NCT00892515已完成不适用

Women In Steady Exercise Research (WISER) Sister

Abramson Cancer Center at Penn Medicine1 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
1
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
是

入选标准

  • •DISEASE CHARACTERISTICS:
  • •Healthy women with ≥ 18% lifetime risk for breast cancer as evidenced by the following:
  • •Documentation from a genetic counselor of a known familial breast cancer susceptibility mutation
  • •Claus model risk of ≥18%
  • •Predicted probability of BRCA1/2 mutation > 25% based on the Myriad model
  • •Documentation of a known mutation in a family member such that the Mendelian probability of a BRCA1/2 mutation would be >25%
  • •History of lobular carcinoma in situ
  • •No prior prophylactic mastectomy
  • •Leisure-time exercise energy expenditure of ≤ 500 kcal/week over the past 6 months
  • •Hormone receptor status not specified
  • •PATIENT CHARACTERISTICS:
  • •Premenopausal
  • •Menstrual cycles 25-32 days in length
  • •Intact ovaries and uterus
  • •Gynecologic age (defined as participant's current age minus the age at which she started menstruating) of at least 4 years
  • •Body mass index 21-50
  • •No history of menstrual difficulties
  • •No history of physician-diagnosed gynecological disease (e.g., fibroids, endometriosis, or polycystic ovary syndrome)
  • •Not pregnant
  • •Not planning to become pregnant during the study period
  • •No medical conditions or medications that would prohibit participation in aerobic exercise or would negatively impact the study
  • •No history of cancer, except nonmelanoma skin cancers, and in situ cervical cancers
  • •No eating disorders (e.g., bulimia or binge-eating disorder)
  • •At least one year since prior smoking
  • •Not planning to move away from the area during the period of the study
  • •No concurrent participation in any weight loss programs
  • •PRIOR CONCURRENT THERAPY:
  • •See Disease Characteristics
  • •At least 3 months since prior hormonal contraception
  • •Must use effective non-hormonal contraception unless participant has undergone prior tubal ligation
  • •Consumes no more than 7 alcoholic beverages per week

排除标准

  • 未提供

研究组 & 干预措施

exercise

Experimental

干预措施: immunologic technique (Other)

exercise

Experimental

干预措施: laboratory biomarker analysis (Other)

exercise

Experimental

干预措施: mass spectrometry (Other)

exercise

Experimental

干预措施: physiologic testing (Other)

exercise

Experimental

干预措施: questionnaire administration (Other)

exercise

Experimental

干预措施: survey administration (Other)

exercise

Experimental

干预措施: dual x-ray absorptometry (Procedure)

exercise

Experimental

干预措施: magnetic resonance imaging (Procedure)

exercise

Experimental

干预措施: study of high risk factors (Procedure)

exercise

Experimental

干预措施: exercise intervention (Behavioral)

exercise

Experimental

干预措施: counseling intervention (Other)

exercise

Experimental

干预措施: gas chromatography (Other)

exercise

Experimental

干预措施: immunoenzyme technique (Other)

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 (1)

Loading locations...

相似试验