BC: A Pilot Clinical Trial With Tocotrienol on Breast Cancer

Sponsor

Malaysia Palm Oil Board (Other)

Overall Status

Completed

CT.gov ID

NCT01157026

Collaborator

(none)

240

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Dietary Supplement: Tocotrienol Rich Fraction (TRF) Other: placebo plus tamoxifen	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2001

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tocotrienol Rich Fraction plus Tamoxifen	Dietary Supplement: Tocotrienol Rich Fraction (TRF) Tocotrienol Rich Fraction (200mg), daily for five years Other Names: Tocotrienol Rich Fraction (Hovid Sdn.Bhd)
Active Comparator: Placebo plus tamoxifen	Other: placebo plus tamoxifen 20mg tamoxifen daily

Arm

Intervention/Treatment

Experimental: Tocotrienol Rich Fraction plus Tamoxifen

Dietary Supplement: Tocotrienol Rich Fraction (TRF)

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

Other Names:

Tocotrienol Rich Fraction (Hovid Sdn.Bhd)

Active Comparator: Placebo plus tamoxifen

Other: placebo plus tamoxifen

20mg tamoxifen daily

Outcome Measures

Primary Outcome Measures

breast cancer specific survival [Five Years]
defined as the time from minimization to death due to breast cancer

Secondary Outcome Measures

disease free survival [Five years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).