Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer
NCT ID: NCT02454517
Last Updated: 2023-01-04
Study Results
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View full resultsBasic Information
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TERMINATED
NA
117 participants
INTERVENTIONAL
2016-05-19
2021-09-30
Brief Summary
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Detailed Description
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I. To test whether the Diabetes Prevention Program (DPP) lifestyle intervention (versus \[vs.\] control) improves serum fasting glucose.
II. To test whether the DPP lifestyle intervention (vs. control) improves serum biomarkers of glucose regulation (insulin, C-peptide, insulin-like growth factor-1 \[IGF-1\], IGF binding protein 3 \[IGF-BP3\] and adiponectin).
III. To test whether the DPP lifestyle intervention decreases the levels of insulin receptor or insulin-like growth factor-1 receptor (IGF-1R) in prostate cancer (PCa) tissue epithelium on follow-up prostate biopsy.
IV. To test whether PCa patients randomized to the DPP lifestyle intervention sustain the lifestyle changes for at least 6 months after the end of the intervention period.
SECONDARY OBJECTIVES:
I. To evaluate whether the DPP lifestyle intervention improves health-related quality of life.
II. To evaluate whether the DPP lifestyle intervention effects on pathologic features of follow-up prostate biopsies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients meet with a nutritionist 11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
ARM II: Patients receive oral and written information based on general U.S. dietary and physical activity guidelines along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week.
After completion of study, patients are followed up at 3, 6, and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (diet and exercise lifestyle intervention)
The goals of the diet and exercise lifestyle intervention is for patients to lose 7% total body weight. Patients meet with a nutritionist 11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
Behavioral Dietary Intervention
Undergo DPP lifestyle intervention
Exercise Intervention
Undergo DPP lifestyle intervention
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (control)
Patients receive an informational intervention along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week.
Informational Intervention
Receive oral and written guidelines and meet with dietician
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral Dietary Intervention
Undergo DPP lifestyle intervention
Exercise Intervention
Undergo DPP lifestyle intervention
Informational Intervention
Receive oral and written guidelines and meet with dietician
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary treatment is active surveillance (AS) with planned annual surveillance biopsies
* Body mass index (BMI) \>= 25 kg/m\^2; and
* Physically able to undertake a diet and exercise program
Exclusion Criteria
* Steroid hormone use (antiandrogen therapy \[ADT\]) within the past 12 months
* Significant cardiovascular disease precluding an exercise program, including recent (within 6 months) myocardial infarction or stroke, pulmonary edema, myocarditis, pericarditis, unstable angina, pulmonary embolism/deep venous thrombosis (PE/DVT), uncontrolled hypertension (systolic blood pressure \[SBP\] \> 200; diastolic blood pressure \[DBP\] \> 110), uncontrolled arrhythmia, heart failure; or
* Insulin dependent diabetes mellitus (DM) and/or metformin use
* Doctor of medicine (MD) confirmed cognitive impairment
* Current alcohol or narcotic abuse
40 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Jonathan Wright
Professor
Principal Investigators
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Jonathan Wright
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2015-00686
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG1001233
Identifier Type: OTHER
Identifier Source: secondary_id
9369
Identifier Type: -
Identifier Source: org_study_id
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