Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Proliferative Markers in Endometrium Before and After HIIT Exercises
研究概览
简要总结
This interventional trial recruits women with endometrial cancer to participate in high intensity interval training (HIIT) prior to their standard of care surgery. The study will evaluate tissue and blood to determine if HIIT training has anti-cancer effects. P
详细描述
Primary Objectives:
1. Determine the anti-proliferative effect of HIIT on the endometrium of women with endometrial cancer 2. Participants will undergo baseline testing, be taught how to perform personalized HIIT training prior to surgery, and repeat testing after surgery. Tissue specimens will be collected from standard of care biopsy (no extra biopsy needed) and during surgery. Blood will be collected twice during standard of care blood draws.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of endometrial cancer who are to undergo hysterectomy and staging
- •Between 40-75 years old
- •Body mass index of 30-50 kg/m2
- •Endometrioid histology endometrial cancer
- •Presumed clinically early stage disease (disease confined to uterus only)
- •Have access to a Smart Phone
- •Have access to email
- •Agree to visit the exercise and sport science laboratory within 2 days of SOC visit for baseline testing if enrollment procedures cannot be done on the same day.
- •Agree to visit clinic 2 (+/-2wks) weeks after surgery for SOC follow-up and post surgery visit, or willing to return to exercise and sport science laboratory 2 (+/-2wks) weeks post-surgery
排除标准
- •Meets American College of Sports Medicine Guidelines for physical activity (150 minutes / week)
- •Currently doing HIIT
- •Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
- •Active diagnosis of psychosis or current uncontrolled substance abuse disorder
- •Insulin-dependent diabetes
- •Currently in another EC intervention
- •Severe dementia or other memory loss condition
- •Severe mental health disorder
- •Severely impaired hearing or speech
- •Inability to speak English
- •Musculoskeletal or neuromuscular condition that limits physical activity Any condition, in the opinion of the investigators, which would prohibit safe participation.
结局指标
主要结局
Change in Proliferative Markers in Endometrium Before and After HIIT Exercises
时间窗: 3 years
Change in Ki-67 proliferation values within the HIIT intervention group between the initial biopsy and the surgical biopsy. The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (\<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (\>30%): Fast-growing, potentially more aggressive.
次要结局
未报告次要终点