A Pilot Clinical Trial With Tocotrienol on Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: Tocotrienol Rich Fraction (TRF); Other: placebo plus tamoxifen

• Registration Number: NCT01157026
• Lead Sponsor: Malaysia Palm Oil Board

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.

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 Timeline

• Study Start: 2001-11
• Primary Completion: 2006-11
• Study Completion: 2010-01
• Status Verified: 2010-07
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-02
• Last Update Submitted: 2010-07-02
• Study First Posted: 2010-07-05
• Last Update Posted: 2010-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tocotrienol Rich Fraction plus Tamoxifen	Tocotrienol Rich Fraction (TRF)	-
Placebo plus tamoxifen	placebo plus tamoxifen	-

Primary Outcome Measures

Name	Time	Method
breast cancer specific survival	Five Years	defined as the time from minimization to death due to breast cancer

Secondary Outcome Measures

Name	Time	Method
disease free survival	Five years

Trial Locations

Locations (1)

Malaysian Palm Oil Board; 🇲🇾 Kajang, Selangor, Malaysia