A Pilot Clinical Trial With Tocotrienol on Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2010-01-31

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tocotrienol Rich Fraction plus Tamoxifen

Group Type EXPERIMENTAL

Tocotrienol Rich Fraction (TRF)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo plus tamoxifen

Group Type ACTIVE_COMPARATOR

placebo plus tamoxifen

Intervention Type OTHER

20mg tamoxifen daily

Interventions

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Tocotrienol Rich Fraction (TRF)

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

Intervention Type DIETARY_SUPPLEMENT

placebo plus tamoxifen

20mg tamoxifen daily

Intervention Type OTHER

Other Intervention Names

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Tocotrienol Rich Fraction (Hovid Sdn.Bhd)

Eligibility Criteria

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Inclusion Criteria

1. women with estrogen receptor positive tumors.
2. 40-60 years of age at the start of the tamoxifen therapy.
3. histologically confirmed primary breast cancer.
4. a tumor that was positive for estrogen receptors, progesterone receptors, or both.
5. 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).