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

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.

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.

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