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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

No Placebo-Only Group

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 4, 8, and 26 weeks post-randomization

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

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

Primary study objectives

Change in weight from baseline to 4 weeks post-randomization

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 13Eligibility criteria met