Spots Global Cancer Trial Database for Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

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Trial Identification

Brief Title: Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

Official Title: Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss

Study ID: NCT03042897

Conditions

Estrogen Receptor Positive

Obesity

Progesterone Receptor Positive

Stage I Uterine Corpus Cancer

Stage IA Uterine Corpus Cancer

Stage IB Uterine Corpus Cancer

Interventions

Dietary Intervention

Exercise Intervention

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Study 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: 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.