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Behavioral Intervention

Whole-Food Plant-Based Diet for Prostate Cancer (WFPBD Trial)

N/A
Recruiting
Led By David M Nanus, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed adenocarcinoma of the prostate
Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 4, 8, and 26 weeks post-randomization
Awards & highlights

WFPBD Trial Summary

This trial is testing whether home-delivered, whole-food, plant-based meals can help men with prostate cancer on ADT manage their weight better than general nutritional counseling.

Who is the study for?
Men over 45 with prostate cancer on androgen-deprivation therapy for at least 24 weeks, who are not currently vegetarian or vegan, without recent chemo/radiation, and no plans to change exercise habits. They must have a good performance status (able to carry out daily activities), adequate organ function, no nut/legume/gluten allergies, and be willing to follow the study procedures.Check my eligibility
What is being tested?
The trial is testing if home-delivered whole-food plant-based meals help control weight better than standard nutritional counseling in overweight men with prostate cancer undergoing hormone therapy.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include gastrointestinal adjustments like bloating or changes in bowel movements as the body adapts to a plant-based diet.

WFPBD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer was confirmed by a lab test.
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I am on hormone therapy for prostate cancer or have had surgery to remove my testicles.
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I have been on hormone therapy for prostate cancer for at least 24 weeks and expect to continue for at least 26 more weeks.
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I have been on anti-androgen therapy for at least 3 months and plan to continue.
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It has been over 3 months since I finished my chemotherapy or radiation.
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I am taking medications for bone health.
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I am 45 years old or older.
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I am fully active or can carry out light work.
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My blood tests show my organs and bone marrow are working well.
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I am willing and able to follow all study procedures.

WFPBD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 4, 8, and 26 weeks post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 4, 8, and 26 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in weight from baseline to 4 weeks post-randomization
Secondary outcome measures
Change in BMI from baseline to 4, 8, and 26 weeks post-randomization.
Change in FACT-P score as an indicator of quality of life from baseline to 4, 8, and 26
Change in levels of HDL from baseline to 4, 8, and 26 weeks post-randomization
+13 more

WFPBD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Whole-food, Plant-based Diet (WFPBD)Experimental Treatment1 Intervention
Home-delivered WFPBD meals will be provided to participants, along with nutritional coaching and education. 12 meals a week will be delivered for the first 4 weeks, followed by 6 meals a week for the next 4 weeks. Finally, for the last 18 weeks they will not receive pre-packed meals, but will continue to receive WFPBD coaching. 30 participants are anticipated to be accrued in this arm.
Group II: General Nutrition CounselingActive Control1 Intervention
Participants will receive general nutritional counseling weekly for the first 4 weeks, followed by monthly nutritional counseling for the following 18 weeks. 30 participants are anticipated to be accrued in this arm.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,234 Total Patients Enrolled
48 Trials studying Prostate Cancer
35,579 Patients Enrolled for Prostate Cancer
Plantable Inc.UNKNOWN
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,720 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,870 Patients Enrolled for Prostate Cancer

Media Library

Whole-food, Plant-Based Diet (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05471414 — N/A
Prostate Cancer Research Study Groups: Whole-food, Plant-based Diet (WFPBD), General Nutrition Counseling
Prostate Cancer Clinical Trial 2023: Whole-food, Plant-Based Diet Highlights & Side Effects. Trial Name: NCT05471414 — N/A
Whole-food, Plant-Based Diet (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05471414 — N/A

Frequently Asked Questions

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

Are seniors aged 70+ being enlisted in this research trial?

"This trial allows for the inclusion of participants aged 45 to 99. Conversely, there are 76 trials targeting those below 18 years old and 1315 involving individuals 65 or older."

Answered by AI

Are there any vacancies for volunteers in this trial?

"Per information on clinicaltrials.gov, this medical trial is still seeking participants - the original posting occurred on September 22nd 2022 and was last modified on November 9th of the same year."

Answered by AI

How many participants are being taken into account for this research?

"Affirmative. Clinicaltrials.gov data indicates that this scientific trial, which first became available on September 22nd 2022, is actively recruiting patients from 3 different sites with a total enrollment goal of 60 individuals."

Answered by AI

Who would be the ideal volunteers for this clinical research?

"Eligible patients must possess prostate cancer and be at least 45 years of age but no older than 99. Currently, the clinical trial is open to approximately 60 subjects."

Answered by AI

Who else is applying?

What site did they apply to?
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm recently diagnosed with prostrate cancer. Psa level 3.4. Linker score of 5. Biopsy scheduled for 10/11. I had no symptoms leading to this diagnosed. I would like to stay away from chemo and radiation. And extensive surgery.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Weill Cornell Medicine: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer
2022. "Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05471414.
~23 spots leftby Apr 2025
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