A Pilot Clinical Trial With Tocotrienol on Breast Cancer (BC)

July 2, 2010 updated by: Malaysia Palm Oil Board

Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial

Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer specific survival and recurrence free survival, in women with early breast cancer and estrogen receptor positive tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did not have any influence in the trial designing, patient recruitment, data collection, analysis and reporting. The placebo drug which contained soy oil without tocotrienols had similar appearance and taste as the TRF drug. A total of 240 women breast cancer patients were assigned to two groups by minimization method that balanced treatment groups. The intervention group was given TRF plus tamoxifen, (n = 120) while control group was given placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival, defined as the time from minimization to death due to breast cancer. The secondary end points included disease free survival, biochemical parameters, liver function and plasma levels of vitamin E.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Malaysian Palm Oil Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  1. women with estrogen receptor positive tumors.
  2. 40-60 years of age at the start of the tamoxifen therapy.
  3. histologically confirmed primary breast cancer.
  4. a tumor that was positive for estrogen receptors, progesterone receptors, or both.
  5. an Eastern Cooperative Oncology Group performance status of 0,1, or 2 (scored on a scale of 0 to 5, with lower scores indicating better function).

Exclusion criteria:

  1. concurrent use of investigational drugs and estrogen receptor status negative or unknown.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tocotrienol Rich Fraction plus Tamoxifen
Dietary supplement: Tocotrienol Rich Fraction (TRF)
Tocotrienol Rich Fraction (200mg), daily for five years
Other Names:
  • Tocotrienol Rich Fraction (Hovid Sdn.Bhd)
Active Comparator: Placebo plus tamoxifen
Other: placebo plus tamoxifen
20mg tamoxifen daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast cancer specific survival
Time Frame: Five Years
defined as the time from minimization to death due to breast cancer
Five Years

Secondary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malaysia Palm Oil Board

Investigators

  • Principal Investigator: Kalanithi Nesaretnam, PhD, Malaysia Palm Oil Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Estimate)

July 5, 2010

Last Update Submitted That Met QC Criteria

July 2, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT369
  • 5399 S1 (Registry Identifier: National Medical Research Register,Malaysia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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