Breast Cancer Female
Conditions
Keywords
MTD, TRF, Pharmacology
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 tolerated dose: MTD) that can be used in women with breast cancer.
Detailed description
3+3 step up design method will be used in this study.
Interventions
DIETARY_SUPPLEMENTTocotrienol-rich Fraction (TRF)
TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol
Sponsors
Malaysia Palm Oil Board
Nur Aishah Mohd Taib
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single arm intervention study 3+3 step up design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Assessment | For 2 to 4 weeks during supplementation | Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 |
| Liver Function Test | For 2 to 4 weeks during supplementation | Liver enzymes with units of U/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailability of TRF | For 2 to 4 weeks during supplementation | Blood pharmacokinetic parameters |
Countries
Malaysia
Contacts
Primary ContactNur Aishah Taib, MBBS
Outcome results
None listed