NCT01157026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Nov 2001

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
Last Updated

July 5, 2010

Status Verified

July 1, 2010

Enrollment Period

5 years

First QC Date

July 1, 2010

Last Update Submit

July 2, 2010

Conditions

Breast Cancer

Keywords

Breast cancerTocotrienol-rich fraction with tamoxifen

Outcome Measures

Primary Outcomes (1)

  • breast cancer specific survival

    defined as the time from minimization to death due to breast cancer

    Five Years

Secondary Outcomes (1)

  • disease free survival

    Five years

Study Arms (2)

Tocotrienol Rich Fraction plus Tamoxifen

EXPERIMENTAL
Dietary Supplement: Tocotrienol Rich Fraction (TRF)

Placebo plus tamoxifen

ACTIVE COMPARATOR
Other: placebo plus tamoxifen

Interventions

Tocotrienol Rich Fraction (TRF)DIETARY_SUPPLEMENT

Tocotrienol Rich Fraction (200mg), daily for five years

Also known as: Tocotrienol Rich Fraction (Hovid Sdn.Bhd)
Tocotrienol Rich Fraction plus Tamoxifen
placebo plus tamoxifenOTHER

20mg tamoxifen daily

Placebo plus tamoxifen

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with estrogen receptor positive tumors.
  • years of age at the start of the tamoxifen therapy.
  • histologically confirmed primary breast cancer.
  • a tumor that was positive for estrogen receptors, progesterone receptors, or both.
  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 20929592DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Kalanithi Nesaretnam, PhD

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 5, 2010

Study Start

November 1, 2001

Primary Completion

November 1, 2006

Study Completion

January 1, 2010

Last Updated

July 5, 2010

Record last verified: 2010-07

Locations

MY(1)