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 tolerated dose: MTD) that can be used in women with breast cancer.
3+3 step up design method will be used in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol
University of Malaya Medical Center
Kuala Lumpur, Malaysia
RECRUITINGPhysical Assessment
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Time frame: For 2 to 4 weeks during supplementation
Liver Function Test
Liver enzymes with units of U/L
Time frame: For 2 to 4 weeks during supplementation
Bioavailability of TRF
Blood pharmacokinetic parameters
Time frame: For 2 to 4 weeks during supplementation
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