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| Name | Class |
|---|---|
| Malaysia Palm Oil Board | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocotrienol-rich Fraction (TRF) | Experimental | Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol-rich Fraction (TRF) | Dietary Supplement | TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Assessment | Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 | For 2 to 4 weeks during supplementation |
| Liver Function Test | Liver enzymes with units of U/L | For 2 to 4 weeks during supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability of TRF | Blood pharmacokinetic parameters | For 2 to 4 weeks during supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nur Aishah Taib, MBBS | Contact | +60379493642 | nuraish@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nur Aishah Taib, MBBS | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya Medical Center | Recruiting | Kuala Lumpur | Malaysia |
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Single arm intervention study 3+3 step up design
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