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Behavioural Intervention

Intermittent Fasting for Prostate Cancer

N/A

Recruiting

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

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

Must have

Have measurable prostate cancer disease and be eligible for androgen deprivation therapy

Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial tests if a diet of limited food and more plants can help prostate cancer patients. It will measure how well people stick to the diet and if it helps.

Who is the study for?

This trial is for prostate cancer patients who are currently undergoing androgen deprivation therapy. It's designed to see if they can stick to a schedule of intermittent fasting, with the option to follow a plant-enriched diet.Check my eligibility

What is being tested?

The study is testing whether intermittent fasting (with or without a plant-enriched diet) is practical for these patients. The focus is on how well participants can enroll, stay in the study, and follow the dietary guidelines.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include hunger, fatigue, irritability or other symptoms related to changes in eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have prostate cancer that can be measured and I am eligible for hormone therapy.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a male aged 18 or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

Drop-out rate

Enrollment rate

Secondary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intermittent FastingExperimental Treatment1 Intervention

Patients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor

247 Previous Clinical Trials

49,502 Total Patients Enrolled

1 Trials studying Prostate Cancer

Frequently Asked Questions

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

How many individuals are permitted to participate in this research endeavor?

"Correct. Data hosted on clinicaltrials.gov affirms that this research effort, which was first posted on December 5th 2023, is now looking for volunteers. A total of 30 individuals are needed to be onboarded from one medical facility."

Answered by AI

Are there still openings for prospective participants in this clinical research project?

"The clinical trial is actively recruiting as indicated by the data published on clinicaltrials.gov, with the initial post dated December 5th 2023 and its most recent edit occurring a week later."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Roberto Pili 2023. "Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06172283.