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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01684 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 5U-16-1 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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PI left institution
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (exercise and diet) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Dietary Supplement | Undergo DASH diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory Fitness (CRF) | Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake. | Up to 34 weeks |
| Cardiovascular (CV) health outcomes | Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound. The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques. | Up to 34 weeks |
| Depression measured by Center for Epidemiologic Studies Depression scale | Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21). | Up to 34 weeks |
| Fatigue measured by the Brief Fatigue Inventory | Will be assessed on a continuum scale and thus our current plan is to use paired t tests. All analysis will be performed using SPSS (v.21). | Up to 34 weeks |
| Muscle strength | The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention. | Up to 34 weeks |
| Percent weight loss at the completion of the intervention | Each of the 25 women will be classified as having achieve the 10% weight-loss or not. Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated. The mean percent weight loss, as well as the range and quartiles will be calculated. In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g. inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.). This information will guide the design (or redesign of the weight loss program as well as the follow-up studies. |
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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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Exercise Intervention | Behavioral | Undergo in aerobic exercise |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| At 16 weeks |
| Quality of Life (QOL) | The SF-36 short-form health survey with 36 items will be used to assess physical and mental health. The FACT-En questionnaire will also be used. This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants. | Up to 34 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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