A Pilot Clinical Trial With Tocotrienol on Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: Tocotrienol Rich Fraction (TRF)
* Other: placebo plus tamoxifen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tocotrienol Rich Fraction plus Tamoxifen<br> | Dietary Supplement: Tocotrienol Rich Fraction (TRF)<br>* Tocotrienol Rich Fraction (200mg), daily for five years<br>* Other names: Tocotrienol Rich Fraction (Hovid Sdn.Bhd);|
| Active Comparator: Placebo plus tamoxifen<br> | Other: placebo plus tamoxifen<br>* 20mg tamoxifen daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast cancer specific survival | defined as the time from minimization to death due to breast cancer | Five Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Tocotrienol-rich fraction with tamoxifen