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

NCT03855423 | Unknown DMC

• 1 other identifier: 853.4
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

MTD; TRF; Pharmacology

Outcome Measures

Primary Outcomes (2)

• Physical Assessment

  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

  Liver enzymes with units of U/L

  For 2 to 4 weeks during supplementation

Secondary Outcomes (1)

• Bioavailability of TRF

  For 2 to 4 weeks during supplementation

Study Arms (1)

Tocotrienol-rich Fraction (TRF)

EXPERIMENTAL

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

Tocotrienol-rich Fraction (TRF) DIETARY_SUPPLEMENT

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

Also known as: Tocovid Suprabio

Tocotrienol-rich Fraction (TRF)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nur Aishah Mohd Taib: lead
• Malaysia Palm Oil Board: collaborator

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, Malaysia

RECRUITING

Study Officials

• Nur Aishah Taib, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Aishah Taib, MBBS

CONTACT

+60379493642; nuraish@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single arm intervention study 3+3 step up design

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 26, 2019
• Study Start: February 18, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)