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

Primary Purpose

Breast Cancer Female

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Tocotrienol-rich Fraction (TRF)
Sponsored by
Nur Aishah Mohd Taib
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer Female focused on measuring MTD, TRF, Pharmacology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Malaya Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tocotrienol-rich Fraction (TRF)

Arm Description

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

Outcomes

Primary Outcome Measures

Physical Assessment
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Liver Function Test
Liver enzymes with units of U/L

Secondary Outcome Measures

Bioavailability of TRF
Blood pharmacokinetic parameters

Full Information

First Posted
February 14, 2019
Last Updated
April 18, 2019
Sponsor
Nur Aishah Mohd Taib
Collaborators
Malaysia Palm Oil Board
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1. Study Identification

Unique Protocol Identification Number
NCT03855423
Brief Title
Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer
Acronym
Matriac
Official Title
Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nur Aishah Mohd Taib
Collaborators
Malaysia Palm Oil Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
MTD, TRF, Pharmacology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm intervention study 3+3 step up design
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tocotrienol-rich Fraction (TRF)
Arm Type
Experimental
Arm Description
Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tocotrienol-rich Fraction (TRF)
Other Intervention Name(s)
Tocovid Suprabio
Intervention Description
TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol
Primary Outcome Measure Information:
Title
Physical Assessment
Description
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Time Frame
For 2 to 4 weeks during supplementation
Title
Liver Function Test
Description
Liver enzymes with units of U/L
Time Frame
For 2 to 4 weeks during supplementation
Secondary Outcome Measure Information:
Title
Bioavailability of TRF
Description
Blood pharmacokinetic parameters
Time Frame
For 2 to 4 weeks during supplementation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nur Aishah Taib, MBBS
Phone
+60379493642
Email
nuraish@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur Aishah Taib, MBBS
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya Medical Center
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nur Aishah Taib, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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