Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cardiorespiratory Fitness (CRF)
研究概览
简要总结
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cardiorespiratory Fitness (CRF)
时间窗: 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.
Depression measured by Center for Epidemiologic Studies Depression scale
时间窗: 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).
Fatigue measured by the Brief Fatigue Inventory
时间窗: 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).
Percent weight loss at the completion of the intervention
时间窗: At 16 weeks
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.
Quality of Life (QOL)
时间窗: 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.
Cardiovascular (CV) health outcomes
时间窗: 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.
Muscle strength
时间窗: 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.
次要结局
未报告次要终点