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

April 18, 2019 updated by: Nur Aishah Mohd Taib

Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • University of Malaya Medical Center
        • Contact:
          • Nur Aishah Taib, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol
Other Names:
  • Tocovid Suprabio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Assessment
Time Frame: For 2 to 4 weeks during supplementation
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
Time Frame: For 2 to 4 weeks during supplementation
Liver enzymes with units of U/L
For 2 to 4 weeks during supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioavailability of TRF
Time Frame: For 2 to 4 weeks during supplementation
Blood pharmacokinetic parameters
For 2 to 4 weeks during supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nur Aishah Mohd Taib

Collaborators

Malaysia Palm Oil Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 18, 2019

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (ACTUAL)

February 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 853.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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