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

This study has been completed.
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Puvaneswari Meganathan, Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01571921
First received: March 26, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 1a: A Randomized, 2-period Cross-over Study to Compare the Bioavailability of Gamma-Delta Tocotrienol (GDT) With That of Tocotrienol Rich Fraction (TRF) in Twelve Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax)of drug [ Time Frame: 0 to 24 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gamma-Delta Tocotrienol with Tocotrienol Rich Fraction (TRF) Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction
Single oral TRF or Gamma-Delta Tocotrienol dosage

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571921

Locations
Malaysia
University Malaya Medical Centre(UMMC)
Lembah Pantai,, Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
Malaysia Palm Oil Board
University of Malaya
Investigators
Principal Investigator: Nur Aishah Mohd Taib University Malaya Medical Centre
  More Information

Publications:

Responsible Party: Puvaneswari Meganathan, Ms, Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT01571921     History of Changes
Other Study ID Numbers: 896.128
Study First Received: March 26, 2012
Last Updated: July 22, 2014
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Vitamin E
Tocotrienols
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014