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

University of Southern California

Status: Withdrawn

Conditions: Stage I Uterine Corpus Cancer; Progesterone Receptor Positive; Obesity; Estrogen Receptor Positive; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer

Treatments: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Dietary Supplement: Dietary Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03042897

NCI-2016-01684 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

5U-16-1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive Care (exercise and diet)

Experimental group

Description:

Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.

Treatment:

Dietary Supplement: Dietary Intervention

Other: Quality-of-Life Assessment

Other: Laboratory Biomarker Analysis

Behavioral: Exercise Intervention