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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01571921
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Puvaneswari Meganathan, Malaysia Palm Oil Board

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : January 2013
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gamma-Delta Tocotrienol Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction
Single oral TRF or Gamma-Delta Tocotrienol dosage
Active Comparator: TRF Dietary Supplement: Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction
Single oral TRF or Gamma-Delta Tocotrienol dosage


Outcome Measures
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Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax)of drug [ Time Frame: 0 to 24 hours after dosing ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571921


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

Other Publications:

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Responsible Party: Puvaneswari Meganathan, Ms, Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT01571921    
Other Study ID Numbers: 896.128
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients