Trial | NCT01157026  Report issue

Title

A Pilot Clinical Trial With Tocotrienol on Breast Cancer
Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tocotrienol ...

  • Study Participants

    240
Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer specific survival and recurrence free survival, in women with early breast cancer and estrogen receptor positive tumors.
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.
Study Started
Nov 30
2001
Primary Completion
Nov 30
2006
Study Completion
Jan 31
2010
Last Update
Jul 05
2010
Estimate

Dietary Supplement Tocotrienol Rich Fraction (TRF)

Tocotrienol Rich Fraction (200mg), daily for five years

  • Other names: Tocotrienol Rich Fraction (Hovid Sdn.Bhd)

Other placebo plus tamoxifen

20mg tamoxifen daily

Tocotrienol Rich Fraction plus Tamoxifen Experimental

Placebo plus tamoxifen Active Comparator

Criteria 

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.
No Results Posted