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Clinical Trial

Olive Oil for High Risk Breast Cancer Prevention in Women

This is a single-arm, pilot breast cancer prevention study of hydroxytyrosol in women at increased risk of breast cancer. Our primary study endpoint will be defined as proportion of women who exhibit a 10% absolute reduction in mammographic density at one-year of follow-up (Cuzick JNCI 2011). For each of the post and pre-menopausal group of women, we will assume under the null hypothesis that 25% of women will exhibit a response (at least a 25% reduction from baseline) versus an alternative hypothesis equal to 45% based on data presented from Cuzick (JNCI 2011). Under these assumptions, a sample of 50 pre-menopausal and 50 post-menopausal women will provide 85% power based on a two-sided test for a single proportion with 5% significance level for each group of women.
Clinical Trial

A PILOT STUDY OF HYDROXYTYROSOL, A COMPONENT OF OLIVE OIL FOR BREAST CANCER PREVENTION IN WOMEN AT HIGH RISK OF BREAST CANCER (CTMS# 16-0068)

This is a single-arm, pilot breast cancer prevention study of hydroxytyrosol in women at increased risk of breast cancer. Our primary study endpoint will be defined as proportion of women who exhibit a 10% absolute reduction in mammographic density at one-year of follow-up (Cuzick JNCI 2011). For each of the post and pre-menopausal group of women, we will assume under the null hypothesis that 25% of women will exhibit a response (at least a 25% reduction from baseline) versus an alternative hypothesis equal to 45% based on data presented from Cuzick (JNCI 2011). Under these assumptions, a sample of 50 pre-menopausal and 50 post-menopausal women will provide 85% power based on a two-sided test for a single proportion with 5% significance level for each group of women.
Clinical Trial

S0820, "A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colo

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.
Clinical Trial

S0820, Adenoma and Second Primary Prevention Trial

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.