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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

Must not have

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment

Is not willing and able to provide written informed consent for the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been in a clinical trial for a new treatment or device in the last 4 weeks.

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I cannot or will not sign the consent form for this trial.

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I need assistance with my daily activities.

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I have another cancer that is getting worse or needs treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drop-out rate

Enrollment rate

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met