Status:
UNKNOWN
Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer
Lead Sponsor:
Nur Aishah Mohd Taib
Collaborating Sponsors:
Malaysia Palm Oil Board
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal t...
Detailed Description
3+3 step up design method will be used in this study.
Eligibility Criteria
Inclusion
- Patients with operable breast cancer
- Life expectancy of at least 3 months
- Adequate organ function
- No allergy to Vitamin E and TRF
- Provides consent to participate in trial and adhere to the study protocol
Exclusion
- Receiving concomitant chemotherapy, radiotherapy, hormonal, immune therapy or other investigational drugs
- Uncontrolled concurrent illness
- Pregnant / breast feeding women
- Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03855423
Start Date
February 18 2019
End Date
December 31 2019
Last Update
April 19 2019
Active Locations (1)
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1
University of Malaya Medical Center
Kuala Lumpur, Malaysia