A Pilot Clinical Trial With Tocotrienol on Breast Cancer

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2006

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.

Interventions

  • Dietary Supplement: Tocotrienol Rich Fraction (TRF)
    • Tocotrienol Rich Fraction (200mg), daily for five years
  • Other: placebo plus tamoxifen
    • 20mg tamoxifen daily

Arms, Groups and Cohorts

  • Experimental: Tocotrienol Rich Fraction plus Tamoxifen
  • Active Comparator: Placebo plus tamoxifen

Clinical Trial Outcome Measures

Primary Measures

  • breast cancer specific survival
    • Time Frame: Five Years
    • defined as the time from minimization to death due to breast cancer

Secondary Measures

  • disease free survival
    • Time Frame: Five years

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Malaysia Palm Oil Board
  • Provider of Information About this Clinical Study
    • Kalanithi Nesaretnam, Malaysian Palm Oil Board
  • Overall Official(s)
    • Kalanithi Nesaretnam, PhD, Principal Investigator, Malaysia Palm Oil Board

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