A Pilot Clinical Trial With Tocotrienol on Breast Cancer

We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did not have any influence in the trial designing, patient recruitment, data collection, analysis and reporting. The placebo drug which contained soy oil without tocotrienols had similar appearance and taste as the TRF drug. A total of 240 women breast cancer patients were assigned to two groups by minimization method that balanced treatment groups. The intervention group was given TRF plus tamoxifen, (n = 120) while control group was given placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival, defined as the time from minimization to death due to breast cancer. The secondary end points included disease free survival, biochemical parameters, liver function and plasma levels of vitamin E.

Inclusion criteria

• women with estrogen receptor positive tumors.
• 40-60 years of age at the start of the tamoxifen therapy.
• histologically confirmed primary breast cancer.
• a tumor that was positive for estrogen receptors, progesterone receptors, or both.
• an Eastern Cooperative Oncology Group performance status of 0,1, or 2 (scored on a scale of 0 to 5, with lower scores indicating better function).

Exclusion criteria

• concurrent use of investigational drugs and estrogen receptor status negative or unknown.