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

• Sponsor: Nur Aishah Mohd Taib (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03855423
• Collaborator: Malaysia Palm Oil Board (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10.4
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Dietary Supplement: Tocotrienol-rich Fraction (TRF)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single arm intervention study 3+3 step up designSingle arm intervention study 3+3 step up design
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer
• Actual Study Start Date: Feb 18, 2019
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Physical Assessment [For 2 to 4 weeks during supplementation]

   Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0

2. Liver Function Test [For 2 to 4 weeks during supplementation]

   Liver enzymes with units of U/L

Secondary Outcome Measures

1. Bioavailability of TRF [For 2 to 4 weeks during supplementation]

   Blood pharmacokinetic parameters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Malaya Medical Center	Kuala Lumpur		Malaysia

Sponsors and Collaborators

• Nur Aishah Mohd Taib
• Malaysia Palm Oil Board

Investigators

• Principal Investigator: Nur Aishah Taib, MBBS, University of Malaya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nur Aishah Mohd Taib, Professor, University of Malaya
• ClinicalTrials.gov Identifier: NCT03855423
• Other Study ID Numbers: 853.4
• First Posted: Feb 26, 2019
• Last Update Posted: Apr 19, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nur Aishah Mohd Taib, Professor, University of Malaya: MTD; TRF; Pharmacology
• Additional relevant MeSH terms: Breast Neoplasms; Tocotrienols; Vitamin E; Tocopherols; Tocovid

Study Results

No Results Posted as of Apr 19, 2019