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

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ClinicalTrials.gov Identifier: NCT03855423
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Malaysia Palm Oil Board
Information provided by (Responsible Party):
Nur Aishah Mohd Taib, University of Malaya

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) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single 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 : February 18, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: Tocovid Suprabio




Primary Outcome Measures :
  1. 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

  2. Liver Function Test [ Time Frame: For 2 to 4 weeks during supplementation ]
    Liver enzymes with units of U/L


Secondary Outcome Measures :
  1. Bioavailability of TRF [ Time Frame: For 2 to 4 weeks during supplementation ]
    Blood pharmacokinetic parameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855423


Contacts
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Contact: Nur Aishah Taib, MBBS +60379493642 nuraish@gmail.com

Locations
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Malaysia
University of Malaya Medical Center Recruiting
Kuala Lumpur, Malaysia
Contact: Nur Aishah Taib, MBBS         
Sponsors and Collaborators
Nur Aishah Mohd Taib
Malaysia Palm Oil Board
Investigators
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Principal Investigator: Nur Aishah Taib, MBBS University of Malaya

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Responsible Party: Nur Aishah Mohd Taib, Professor, University of Malaya
ClinicalTrials.gov Identifier: NCT03855423     History of Changes
Other Study ID Numbers: 853.4
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Malaya:
MTD
TRF
Pharmacology

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances