Overcoming challenges in designing and implementing a phase II randomized controlled trial using a presurgical model to test a dietary intervention in prostate cancer
2008

Dietary Intervention in Prostate Cancer: A Phase II Trial

Sample size: 161 publication Evidence: moderate

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)

10.1177/1740774508091676

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