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Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer

NCT02454517 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2023-01-04

Study results available
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Summary

This randomized phase III trial studies a diet and exercise program based on the Diabetes Prevention Program to promote weight loss and improve health in men with low-risk or low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that promotes weight loss may influence prostate health. A combined diet and exercise program that is based on the Diabetes Prevention Program may affect markers (or "biomarkers") of prostate cancer progression. Gathering this information may help doctors understand how obesity affects prostate cancer progression and may help lead to a program that can reduce the risk of prostate cancer progression.

Conditions

  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer AJCC V7
  • Stage IIA Prostate Cancer AJCC v7

Interventions

BEHAVIORAL

Behavioral Dietary Intervention

Undergo DPP lifestyle intervention

BEHAVIORAL

Exercise Intervention

Undergo DPP lifestyle intervention

OTHER

Informational Intervention

Receive oral and written guidelines and meet with dietician

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Jonathan Wright · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-19
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02454517 on ClinicalTrials.gov