Trials / Withdrawn
WithdrawnNCT03042897
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Estrogen Receptor Positive
- Obesity
- Progesterone Receptor Positive
- Stage I Uterine Corpus Cancer
- Stage IA Uterine Corpus Cancer
- Stage IB Uterine Corpus Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Dietary Intervention | Undergo DASH diet |
| BEHAVIORAL | Exercise Intervention | Undergo in aerobic exercise |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
Timeline
- Start date
- 2017-09-08
- Primary completion
- 2019-07-31
- Completion
- 2019-07-31
- First posted
- 2017-02-03
- Last updated
- 2020-12-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03042897. Inclusion in this directory is not an endorsement.