Description:
This is a randomized control trial testing the effect of walnut supplementation on prostate
cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo
RP. Patients consented to the study will be randomly assigned to either continue their usual
diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their
consent date and the date for RP.
Title
- Brief Title: WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
- Official Title: WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
Clinical Trial IDs
- ORG STUDY ID:
IIT2018-23-Freedland-POWR
- NCT ID:
NCT03824652
Conditions
Purpose
This is a randomized control trial testing the effect of walnut supplementation on prostate
cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo
RP. Patients consented to the study will be randomly assigned to either continue their usual
diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their
consent date and the date for RP.
Detailed Description
The overall objective of this study is to test the effect of walnuts added to a usual diet on
prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects
will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts
daily. The baseline visit will occur in conjunction with a standard of care visit
post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled
date of the standard of care radical prostatectomy (RP), and the final visit will occur in
conjunction with a standard of care visit prior to RP.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Usual Diet + Walnuts | Experimental | Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks | |
| Usual Diet | Active Comparator | Usual diet for 4-10 weeks | |
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed prostate adenocarcinoma.
- Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine
exact tumor location.
- Biopsy grade group 2 or higher (Gleason ≥7).
- Planning to undergo RP.
- Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per
day.
- Reads, writes, and understands English.
- Age 18 or older
Exclusion Criteria:
- Allergy to nuts.
- History of receiving hormone therapy or antiandrogen therapy.
- Use of 5-alpha reductase inhibitors in the past 6 months.
- Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate
cryotherapy.
- Currently enrolled in a modified diet/weight loss program and/or taking dietary
supplements that contain omega-3s (e.g., fish oil).
- Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma
- Significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol/drug
addiction, malabsorption syndromes), that in the opinion of the study physician make
the patient ineligible.
- Individuals with psychological/mental conditions which can affect the consent process
and/or their adherence to the protocol.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP |
| Time Frame: | 10 weeks |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP |
| Time Frame: | 10 weeks |
| Safety Issue: | |
| Description: | Measured by prostate tissue 8-hydroxy-2-deoxyguanosine |
| Measure: | Mean difference in prostatic tissue inflammation from baseline biopsy to RP |
| Time Frame: | 10 weeks |
| Safety Issue: | |
| Description: | Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Stephen Freedland |
Trial Keywords
- prostate cancer
- prostate adenocarcinoma
- diet
- walnuts
- radical prostatectomy
- omega-3 fatty acids
- polyphenols
Last Updated
August 27, 2021
