Clinical trial · Interventional
Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer
Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer
NCT03855423CI-TRIAL-00038253MatriacunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tocotrienol-rich Fraction (TRF) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tocotrienol-rich Fraction (TRF)
- description
- Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level.
- interventionNames
- Dietary Supplement: Tocotrienol-rich Fraction (TRF)
Primary outcomes (2)
- measure
- Physical Assessment
- timeFrame
- For 2 to 4 weeks during supplementation
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
- measure
- Liver Function Test
- timeFrame
- For 2 to 4 weeks during supplementation
- description
- Liver enzymes with units of U/L
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.