WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/2/2019 |
| Start Date: | February 2019 |
| End Date: | January 2023 |
| Contact: | Dana Levin, MPH |
| Email: | Dana.Levin@cshs.org |
| Phone: | 310-423-0333 |
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 6-10 weeks depending on the window between their
consent date and the date for RP.
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 6-10 weeks depending on the window between their
consent date and the date for RP.
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 6-10 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.
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 6-10 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.
Inclusion Criteria:
- Pathologically confirmed prostate adenocarcinoma with biopsy tissue available for
analysis.
- Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine
exact tumor location.
- Biopsy grade group 2 or higher (Gleason ≥7).
- Scheduled 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 and has access to a computer or a Smartphone to
complete ASA24 food diary.
Exclusion Criteria:
- Allergy to walnuts.
- 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.
- 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.
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