Status:
COMPLETED
A Pilot Clinical Trial With Tocotrienol on Breast Cancer
Lead Sponsor:
Malaysia Palm Oil Board
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-60 years
Phase:
NA
Brief Summary
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 positiv...
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 pre...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01157026
Start Date
November 1 2001
End Date
January 1 2010
Last Update
July 5 2010
Active Locations (1)
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1
Malaysian Palm Oil Board
Kajang, Selangor, Malaysia, 43000