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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01571921

First Posted: April 5, 2012

Last Update Posted: September 14, 2016

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.

Collaborator:

University of Malaya

Information provided by (Responsible Party):

Puvaneswari Meganathan, Malaysia Palm Oil Board

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Vitamin E

Drug Information available for: Tocopherol

U.S. FDA Resources

Further study details as provided by Puvaneswari Meganathan, Malaysia Palm Oil Board:

Primary Outcome Measures:

Peak Plasma Concentration (Cmax)of drug [ Time Frame: 0 to 24 hours after dosing ]


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	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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


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 of Malaya

More Information

Publications:

Nesaretnam K, Selvaduray KR, Abdul Razak G, Veerasenan SD, Gomez PA. Effectiveness of tocotrienol-rich fraction combined with tamoxifen in the management of women with early breast cancer: a pilot clinical trial. Breast Cancer Res. 2010;12(5):R81. doi: 10.1186/bcr2726. Epub 2010 Oct 8.

Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.

Mahalingam D, Radhakrishnan AK, Amom Z, Ibrahim N, Nesaretnam K. Effects of supplementation with tocotrienol-rich fraction on immune response to tetanus toxoid immunization in normal healthy volunteers. Eur J Clin Nutr. 2011 Jan;65(1):63-9. doi: 10.1038/ejcn.2010.184. Epub 2010 Sep 22.

Zaiden N, Yap WN, Ong S, Xu CH, Teo VH, Chang CP, Zhang XW, Nesaretnam K, Shiba S, Yap YL. Gamma delta tocotrienols reduce hepatic triglyceride synthesis and VLDL secretion. J Atheroscler Thromb. 2010 Oct 27;17(10):1019-32. Epub 2010 Aug 10.

Comitato R, Nesaretnam K, Leoni G, Ambra R, Canali R, Bolli A, Marino M, Virgili F. A novel mechanism of natural vitamin E tocotrienol activity: involvement of ERbeta signal transduction. Am J Physiol Endocrinol Metab. 2009 Aug;297(2):E427-37. doi: 10.1152/ajpendo.00187.2009. Epub 2009 Jun 2.

Weng-Yew W, Selvaduray KR, Ming CH, Nesaretnam K. Suppression of tumor growth by palm tocotrienols via the attenuation of angiogenesis. Nutr Cancer. 2009;61(3):367-73. doi: 10.1080/01635580802582736.


Responsible Party:	Puvaneswari Meganathan, Ms, Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:	NCT01571921 History of Changes
Other Study ID Numbers:	896.128
First Submitted:	March 26, 2012
First Posted:	April 5, 2012
Last Update Posted:	September 14, 2016
Last Verified:	September 2016

Additional relevant MeSH terms:


Tocotrienols Vitamin E Tocopherols Antioxidants Molecular Mechanisms of Pharmacological Action	Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances

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