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



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:19 - Any
Updated:10/7/2018
Start Date:September 8, 2017
End Date:September 8, 2021
Contact:Christina Dieli-Conwright, PhD
Email:cdieli@usc.edu
Phone:323-442-2180

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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
We found this trial at
1
site
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: Christina Dieli-Conwright, PhD
Phone: 323-442-2905
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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mi
from
Los Angeles, CA
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