Gamma-delta Tocotrienol as Potential Maintenance Treatment in Women With Metastatic Breast Cancer (GEMM1a)

Malaysia Palm Oil Board

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction

Study type

Interventional

Funder types

Other

Identifiers

NCT01571921

896.128

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

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