Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
NCT ID: NCT03042897
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-09-08
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care (exercise and diet)
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.
Dietary Intervention
Undergo DASH diet
Exercise Intervention
Undergo in aerobic exercise
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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Dietary Intervention
Undergo DASH diet
Exercise Intervention
Undergo in aerobic exercise
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Christina Dieli-Conwright, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2016-01684
Identifier Type: REGISTRY
Identifier Source: secondary_id
5U-16-1
Identifier Type: OTHER
Identifier Source: secondary_id
5U-16-1
Identifier Type: -
Identifier Source: org_study_id