Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I 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