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Status unknownNCT03855423MatriacUpdated Apr 19, 2019

Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer

An interventional study of Tocotrienol-rich Fraction (TRF) in Breast Cancer Female, sponsored by Nur Aishah Mohd Taib. Status unknown at 1 site in Malaysia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Nur Aishah Mohd Taib · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

3+3 step up design method will be used in this study.

02

Conditions studied

  • Breast Cancer Female

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Keywords

  • MTD
  • TRF
  • Pharmacology
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 12 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Nur Aishah Mohd Taib as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Tocotrienol-rich Fraction (TRF)

    Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level.

    Dietary Supplement: Tocotrienol-rich Fraction (TRF)

Interventions

  • Dietary supplementTocotrienol-rich Fraction (TRF)

    TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol

    Also known as: Tocovid Suprabio

06

What researchers measure

Primary outcomes

  1. Physical 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

  2. Liver Function Test

    Liver enzymes with units of U/L

    Time frame: For 2 to 4 weeks during supplementation

Secondary outcomes

  1. Bioavailability of TRF

    Blood pharmacokinetic parameters

    Time frame: For 2 to 4 weeks during supplementation

07

Study locations

1 of 1 sites recruiting
  • University of Malaya Medical Center
    Kuala Lumpur, Malaysia
    • Nur Aishah Taib, MBBS · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03855423
Lead sponsor
Nur Aishah Mohd Taib
Collaborators
Malaysia Palm Oil Board
Responsible party
Nur Aishah Mohd Taib (Professor, University of Malaya) — Sponsor-investigator
First posted
Feb 26, 2019
Start date
Feb 18, 2019
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Apr 19, 2019

Study contacts

Nur Aishah Taib, MBBS
Contact
nuraish@gmail.com
+60379493642
Nur Aishah Taib, MBBS
principal investigator · University of Malaya

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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