Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial
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.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
breast cancer specific survival
defined as the time from minimization to death due to breast cancer
Five Years
No
Kalanithi Nesaretnam, PhD
Principal Investigator
Malaysian Palm Oil Board
Malaysia: Ministry of Health
CT369
NCT01157026
November 2001
January 2010
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