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Improving Energy Balance in Men With Prostate Cancer

NCT01886677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-03

No results posted yet for this study

Summary

RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression.

PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.

Conditions

Interventions

BEHAVIORAL

Immediate diet and exercise intervention

Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).

BEHAVIORAL

Delayed diet and exercise intervention

Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Wendy Demark-Wahnefried, PhD, RD · University of Alabama at Birmingham (UAB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01886677 on ClinicalTrials.gov