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

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ClinicalTrials.gov Identifier: NCT01157026
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : July 5, 2010
Sponsor:
Information provided by:
Malaysia Palm Oil Board

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE July 5, 2010
Last Update Posted Date July 5, 2010
Study Start Date  ICMJE November 2001
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
breast cancer specific survival [ Time Frame: Five Years ]
defined as the time from minimization to death due to breast cancer
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
disease free survival [ Time Frame: Five years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Clinical Trial With Tocotrienol on Breast Cancer
Official Title  ICMJE Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Dietary Supplement: Tocotrienol Rich Fraction (TRF)
    Tocotrienol Rich Fraction (200mg), daily for five years
    Other Name: Tocotrienol Rich Fraction (Hovid Sdn.Bhd)
  • Other: placebo plus tamoxifen
    20mg tamoxifen daily
Study Arms  ICMJE
  • Experimental: Tocotrienol Rich Fraction plus Tamoxifen
    Intervention: Dietary Supplement: Tocotrienol Rich Fraction (TRF)
  • Active Comparator: Placebo plus tamoxifen
    Intervention: Other: placebo plus tamoxifen
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2010)
240
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157026
Other Study ID Numbers  ICMJE CT369
5399 S1 ( Registry Identifier: National Medical Research Register,Malaysia )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kalanithi Nesaretnam, Malaysian Palm Oil Board
Study Sponsor  ICMJE Malaysia Palm Oil Board
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kalanithi Nesaretnam, PhD Malaysia Palm Oil Board
PRS Account Malaysia Palm Oil Board
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP