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Carbohydrate Restriction and Prostate Cancer Growth

NCT01763944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2018-10-12

No results posted yet for this study

Summary

No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (\<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.

Conditions

Interventions

BEHAVIORAL

Low carbohydrate diet

The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Robert C. Atkins Foundation

    collaborator OTHER

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Durham VA Medical Center

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Pao-Hwa Lin · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2018-08-20
Completion
2018-08-20

Countries

  • United States

Study Locations

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Diseases
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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 NCT01763944 on ClinicalTrials.gov