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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


N/A
40 Years
60 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

breast cancer specific survival

Outcome Description:

defined as the time from minimization to death due to breast cancer

Outcome Time Frame:

Five Years

Safety Issue:

No

Principal Investigator

Kalanithi Nesaretnam, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Malaysian Palm Oil Board

Authority:

Malaysia: Ministry of Health

Study ID:

CT369

NCT ID:

NCT01157026

Start Date:

November 2001

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Tocotrienol-rich fraction with tamoxifen
  • Breast Neoplasms

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