A Pilot Clinical Trial With Tocotrienol on Breast Cancer (BC)

Malaysia Palm Oil Board

Status: Completed

Conditions: Breast Cancer

Treatments: Other: placebo plus tamoxifen; Dietary Supplement: Tocotrienol Rich Fraction (TRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT01157026

5399 S1 (Registry Identifier)

CT369

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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).

Exclusion criteria

1. concurrent use of investigational drugs and estrogen receptor status negative or unknown.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

Tocotrienol Rich Fraction plus Tamoxifen

Experimental group

Treatment:

Dietary Supplement: Tocotrienol Rich Fraction (TRF)

Placebo plus tamoxifen

Active Comparator group

Treatment:

Other: placebo plus tamoxifen