Tocotrienols and ER+ BC

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Husband11
Husband11 Member Posts: 2,264
edited June 2014 in Complementary and Holistic Medicine and Treatment

Effectiveness of tocotrienol-rich fraction combined with tamoxifen in the management of women with early breast cancer: a pilot clinical trial.

Nesaretnam K, Selvaduray KR, Abdul Razak G, Veerasenan SD, Gomez PA.

Source

Malaysian Palm Oil Board, 6 Persiaran Institusi, Bandar Baru Bangi, Kajang, 43000 Selangor Darul Ehsan, Malaysia. sarnesar@mpob.gov.my.

Abstract

ABSTRACT:

INTRODUCTION:

Basic research has indicated that tocotrienols have potent antiproliferative and proapoptotic effects that would be expected to reduce the effect of breast cancer.

METHODS:

We conducted a double-blinded, placebo-controlled pilot trial to test the effectiveness of adjuvant tocotrienol therapy in combination with tamoxifen for 5 years in women with early breast cancer. Two-hundred-forty women, aged between 40 and 60 years, with either tumor node metastases (TNM) Stage I or II breast cancer and estrogen receptor (ER)-positive tumors were nonrandomly assigned to two groups. The intervention group received tocotrienol-rich fraction (TRF) plus tamoxifen, whereas the control group received placebo plus tamoxifen, for 5 years.

RESULTS:

During the 5 years of the study, eight patients died of breast cancer, whereas in 36 patients, a local or systemic recurrence developed. Five-year breast cancer-specific survival was 98.3% (95% confidence interval (CI), 95.9% to 100%) in the intervention group and 95% (95% CI, 91.1% to 98.9%) in the control group, whereas the 5-year disease-free survival was 86.7% (95% CI, 80.6% to 92.8%) and 83.3% (95% CI, 76.6% to 90.0%), respectively. Risk of mortality due to breast cancer was 60% (HR, 0.40; 95% CI, 0.08 to 2.05) lower in the intervention group versus the controls after adjustment for age, ethnicity, stage, and lymph node status, but this was not statistically significant. Adjuvant TRF therapy was not associated with breast cancer recurrence (HR, 0.84; 95% CI, 0.43 to 1.65).

CONCLUSIONS:

From the current study, no association seems to exist between adjuvant tocotrienol therapy and breast cancer-specific survival in women with early breast cancer.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT01157026.

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Comments

  • Husband11
    Husband11 Member Posts: 2,264
    edited January 2012

    60% reduction in risk of mortality due to breast cancer, but no statistical significance.  I'm thinking they needed a larger study group to confirm statistical significance.  This is disappointing. 

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  • Husband11
    Husband11 Member Posts: 2,264
    edited January 2012

    From the paper:

    Conclusions Results from this study are not sufficient to indicate a significant association between adjuvant tocotrienol therapy and breast cancer survival in women with early breast cancer. It is important to note that accruing evidence suggests that tocotrienols have anticancer effects. Moreover, tamoxifen and tocotrienol in vitro have demonstrated synergy. Although a 60% lower mortality occurred in the intervention group, this result was not statistically significant. Hence, a large randomized trial is certainly warranted in the near future to establish whether tocotrienol adjuvant therapy can significantly improve recurrence or mortality or both.

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  • Husband11
    Husband11 Member Posts: 2,264
    edited January 2012

    Read it all:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3096974/

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