Dietary Intervention in Prostate Cancer: A Phase II Trial
Author Information
Author(s): Wendy Demark-Wahnefried, Stephen L George, Boyd R Switzer, Denise C Snyder, John F Madden, Thomas J Polascik, Mack T Ruffin IV, Robin T Vollmer
Primary Institution: MD Anderson Cancer Center
Hypothesis
Can flaxseed supplementation and dietary fat restriction impact prostate cancer biology and biomarkers?
Conclusion
The trial successfully recruited a diverse sample and demonstrated the feasibility of using a presurgical model to test dietary interventions in prostate cancer.
Supporting Evidence
- The trial achieved its accrual target with a racially-representative sample.
- Low rates of attrition (7%) were observed.
- Collection rates for biospecimens and survey data exceeded 90%.
Takeaway
This study looked at how changing diets with flaxseed and less fat can help men with prostate cancer, and it showed that this approach can be done successfully.
Methodology
A phase II randomized controlled trial using a presurgical model to compare the effects of flaxseed supplementation and dietary fat restriction on prostate cancer.
Potential Biases
Potential biases due to non-blinding and the inability to use placebo controls for dietary interventions.
Limitations
The study faced challenges in recruitment and the complexity of collecting multiple biospecimens.
Participant Demographics
Participants were 70% white and 30% minority, with a mean age of 59.2 years.
Digital Object Identifier (DOI)
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