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NCT03855423 Clinical Trial

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

Breast Cancer Female Clinical Trial

— Matriac  

Official title:
Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03855423
Other study ID # 853.4
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 18, 2019
Est. completion date December 31, 2019

Study information
Verified date April 2019
Source University of Malaya
Contact Nur Aishah Taib, MBBS
Phone +60379493642
Email nuraish@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Tocotrienol-rich Fraction (TRF)
TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol

Locations
Country Name City State
Malaysia University of Malaya Medical Center Kuala Lumpur

Sponsors (2)
Lead Sponsor Collaborator
Nur Aishah Mohd Taib Malaysia Palm Oil Board

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physical Assessment Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0 For 2 to 4 weeks during supplementation
Primary Liver Function Test Liver enzymes with units of U/L For 2 to 4 weeks during supplementation
Secondary Bioavailability of TRF Blood pharmacokinetic parameters For 2 to 4 weeks during supplementation
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