Clinical trial NCT03042897: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Estrogen Receptor Positive
Obesity
Progesterone Receptor Positive
Stage I Uterine Corpus Cancer
Stage IA Uterine Corpus Cancer
Stage IB Uterine Corpus Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-02-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiorespiratory Fitness (CRF)
timeFrame: Up to 34 weeks
measure: Cardiovascular (CV) health outcomes
timeFrame: Up to 34 weeks
measure: Depression measured by Center for Epidemiologic Studies Depression scale
timeFrame: Up to 34 weeks
measure: Fatigue measured by the Brief Fatigue Inventory
timeFrame: Up to 34 weeks
measure: Muscle strength
timeFrame: Up to 34 weeks
measure: Percent weight loss at the completion of the intervention
timeFrame: At 16 weeks
measure: Quality of Life (QOL)
timeFrame: Up to 34 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Christina Dieli-Conwright, PhD
role: PRINCIPAL_INVESTIGATOR
References: