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Carbohydrate restricted diet for Prostate Cancer

Phase 2

Waitlist Available

Led By Stephen Freedland, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is designed to compare the difference in proliferative index between a carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months.

Secondary outcome measures

Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.

Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.

Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment3 Interventions

Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian

Group II: Arm AExperimental Treatment3 Interventions

Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.

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Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

502 Previous Clinical Trials

165,671 Total Patients Enrolled

12 Trials studying Prostate Cancer

2,125 Patients Enrolled for Prostate Cancer

Stephen Freedland, MD5.05 ReviewsPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Prostate Cancer

50 Patients Enrolled for Prostate Cancer

5Patient Review

Dr Freedland was outstanding!! They provided an initial consultation and review of a prior diagnosis from another well-known healthcare organization. I had the same Turp surgery for an enlarged prostate 2 years prior with very mediocre results: pain, difficult recovery, and 10 days with a catheter. Dr Freedland performed Green Light laser surgery for the same Turp procedure with unbelievable results: very little pain, one day with a catheter, and the stream of my urine returned to normal!

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Carbohydrate restricted diet been cleared by regulatory authorities?

"After examining the available evidence, our team at Power assigned a safety score of 2 to Carbohydrate restricted diet as this is only in Phase 2 trials, meaning there are some data points supporting its security but none backing up its efficacy."

Answered by AI

Is enrollment open for this experiment?

"Affirmative. Information hosted on clinicaltrials.gov suggests that this research trial is currently seeking applicants, having first been posted on the 25th of September 2018 and most recently edited on November 4th 2022. The study requires 40 recruits from one medical centre to participate in the experiment."

Answered by AI

How many individuals are engaging in this research endeavor?

"Affirmative. Data hosted on clinicaltrials.gov supports that this research study, which was initially reported on September 25th 2018, is actively seeking participants. Approximately 40 subjects need to be enrolled from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Stephen Freedland 2018. "Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03679260.