Breast Cancer
Conditions
Keywords
Breast cancer, Tocotrienol-rich fraction with tamoxifen
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 positive tumors.
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_SUPPLEMENTTocotrienol Rich Fraction (TRF)
Tocotrienol Rich Fraction (200mg), daily for five years
OTHERplacebo plus tamoxifen
20mg tamoxifen daily
Sponsors
Malaysia Palm Oil Board
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breast cancer specific survival | Five Years | defined as the time from minimization to death due to breast cancer |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival | Five years |
Countries
Malaysia
Outcome results
None listed