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

Not Applicable

• Conditions: Breast Cancer Female
• Interventions: Dietary Supplement: Tocotrienol-rich Fraction (TRF)

• Registration Number: NCT03855423
• Lead Sponsor: Nur Aishah Mohd Taib

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study Start: 2019-02-18
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tocotrienol-rich Fraction (TRF)	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.

Primary Outcome Measures

Name	Time	Method
Physical Assessment	For 2 to 4 weeks during supplementation	Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Liver Function Test	For 2 to 4 weeks during supplementation	Liver enzymes with units of U/L

Secondary Outcome Measures

Name	Time	Method
Bioavailability of TRF	For 2 to 4 weeks during supplementation	Blood pharmacokinetic parameters

Trial Locations

Locations (1)

University of Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia