Women In Steady Exercise Research (WISER) Sister
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
干预措施: immunologic technique (Other)
exercise
干预措施: laboratory biomarker analysis (Other)
exercise
干预措施: mass spectrometry (Other)
exercise
干预措施: physiologic testing (Other)
exercise
干预措施: questionnaire administration (Other)
exercise
干预措施: survey administration (Other)
exercise
干预措施: dual x-ray absorptometry (Procedure)
exercise
干预措施: magnetic resonance imaging (Procedure)
exercise
干预措施: study of high risk factors (Procedure)
exercise
干预措施: exercise intervention (Behavioral)
exercise
干预措施: counseling intervention (Other)
exercise
干预措施: gas chromatography (Other)
exercise
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
