Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
研究概览
地位
详细说明
PRIMARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.
SECONDARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.
TERTIARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.
II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.
OUTLINE:
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.
After completion of study, patients are followed up for 16 weeks.
After completion of study, patients are followed up for 16 weeks.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90033
- USC / Norris Comprehensive Cancer Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical stage I EC
- Low grade disease positive for estrogen and progesterone receptors
- Body mass index (BMI) >= 30 kg/m^2
- No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Self ambulatory and without use of assistive walking devices
- Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)
- Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
Exclusion Criteria:
- Patients with metastatic disease
- BMI =< 29.9 kg/m^2
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Is not self ambulatory and relies on the use of assistive walking devices
- Is a candidate for immediate hysterectomy, following evaluation by a physician
- In judgement of a physician, is not a candidate for progestin agents
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Supportive Care (exercise and diet)
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks.
Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.
|
相关研究
辅助研究
其他名称：
Undergo DASH diet
其他名称：
Undergo in aerobic exercise
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cardiorespiratory Fitness (CRF)
大体时间：Up to 34 weeks
|
Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
|
Up to 34 weeks
|
|
Cardiovascular (CV) health outcomes
大体时间：Up to 34 weeks
|
Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound.
The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.
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Up to 34 weeks
|
|
Depression measured by Center for Epidemiologic Studies Depression scale
大体时间：Up to 34 weeks
|
Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
|
Up to 34 weeks
|
|
Fatigue measured by the Brief Fatigue Inventory
大体时间：Up to 34 weeks
|
Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
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Up to 34 weeks
|
|
Muscle strength
大体时间：Up to 34 weeks
|
The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
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Up to 34 weeks
|
|
Percent weight loss at the completion of the intervention
大体时间：At 16 weeks
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Each of the 25 women will be classified as having achieve the 10% weight-loss or not.
Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated.
The mean percent weight loss, as well as the range and quartiles will be calculated.
In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g.
inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.).
This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.
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At 16 weeks
|
|
Quality of Life (QOL)
大体时间：Up to 34 weeks
|
The SF-36 short-form health survey with 36 items will be used to assess physical and mental health.
The FACT-En questionnaire will also be used.
This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.
|
Up to 34 weeks
|
合作者和调查者
调查人员
- 首席研究员：Christina Dieli-Conwright, PhD、University of Southern California
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 5U-16-1 (其他标识符：USC / Norris Comprehensive Cancer Center)
- P30CA014089 (美国 NIH 拨款/合同)
- NCI-2016-01684 (注册表标识符：CTRP (Clinical Trial Reporting Program))
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