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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Tocotrienol Rich Fraction (TRF) Other: placebo plus tamoxifen Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial
Study Start Date : November 2001
Actual Primary Completion Date : November 2006
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tocotrienol Rich Fraction plus Tamoxifen Dietary Supplement: Tocotrienol Rich Fraction (TRF)
Tocotrienol Rich Fraction (200mg), daily for five years
Other Name: Tocotrienol Rich Fraction (Hovid Sdn.Bhd)
Active Comparator: Placebo plus tamoxifen Other: placebo plus tamoxifen
20mg tamoxifen daily


Outcome Measures
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Primary Outcome Measures :
  1. breast cancer specific survival [ Time Frame: Five Years ]
    defined as the time from minimization to death due to breast cancer


Secondary Outcome Measures :
  1. disease free survival [ Time Frame: Five years ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157026


Locations
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Malaysia
Malaysian Palm Oil Board
Kajang, Selangor, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
Investigators
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Principal Investigator: Kalanithi Nesaretnam, PhD Malaysia Palm Oil Board
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kalanithi Nesaretnam, Malaysian Palm Oil Board
ClinicalTrials.gov Identifier: NCT01157026    
Other Study ID Numbers: CT369
5399 S1 ( Registry Identifier: National Medical Research Register,Malaysia )
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: July 2010
Keywords provided by Malaysia Palm Oil Board:
Breast cancer
Tocotrienol-rich fraction with tamoxifen
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Tocotrienols
Vitamin E
Tocopherols
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients