Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
Description
Brief Summary
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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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