Gamma-delta Tocotrienol as Potential Maintenance Treatment in Women With Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction

• Registration Number: NCT01571921
• Lead Sponsor: Malaysia Palm Oil Board

Brief Summary

Twelve healthy volunteers who fit the inclusion and exclusion criteria and provide written informed consent to participate in the trial will be recruited to compare the rate and extent of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.

Detailed Description

Twelve healthy subjects will be admitted to a clinical study ward on the Day 0. Physical check up and the health status will be confirmed during check in. After fasting for a minimum of 10 hours overnight, each subject will be administered a single dose of TRF or Gamma-Delta after taking a standardized high-fat meal breakfast on Day 1. Thereafter, standard meals will be provided at 4 and 12 hours after dosing. Blood samples (5mL will be taken using an in-dwelling canula placed in the antecubital vein immediately before and at 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, and 24 hours after dosing. Subjects will be admitted for 24 hours and discharged after the last blood sampling. During the study, blood pressure and the heart rate will be monitored regularly for safety profile.

After a one week wash out period, subject will return to the ward and be given the other formulation (TRF or GDT) and the same procedures will be repeated. Any adverse events that arise during the treatment will be recorded and followed up till resolution.

Study Timeline

• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-05
• Study Start: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Male and female aged 21-55 years old
• Good health
• No allergy to vitamin E/ palm oil
• No past (within 3 months) / current use of dietary supplements containing vitamin E

Exclusion Criteria

• History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers
• Candidate for surgery or had undergone surgery in the past 6 months
• Current or past use (last 3 months) of antithrombotic drugs such as antiplatelets (aspirin, ticlopidine), anticoagulants (heparin, warfarin), thrombolytic agents (streptokinase), etc
• Current or past history of cancer
• Pregnant/ breastfeeding women
• Smokers
• Drug or alcohol abuse
• Hypercholesterolemia
• Chronic conditions such as uncontrolled hypertension, heart disease (ischemic heart disease, heart failure, cardiac arrhythmia), uncontrolled diabetes, HIV infection, or other psychiatric illness/ social situations that might limit adherence to study protocol.
• Unable or unwilling to stop taking vitamins, herbal preparations or nonprescription medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gamma-Delta Tocotrienol	Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction	-
TRF	Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction	-

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)of drug	0 to 24 hours after dosing

Trial Locations

Locations (1)

University Malaya Medical Centre(UMMC); 🇲🇾 Lembah Pantai,, Kuala Lumpur, Malaysia