Effectiveness of tocotrienol-rich fraction combined with tamoxifen in the management of women with early breast cancer: a pilot clinical trial
2010

Tocotrienol and Tamoxifen for Early Breast Cancer

Sample size: 240 publication Evidence: low

Author Information

Author(s): Nesaretnam Kalanithi, Selvaduray Kanga Rani, Abdul Razak Ghazali, Veerasenan Sheela Devi, Gomez Patricia A

Primary Institution: Malaysian Palm Oil Board

Hypothesis

Tocotrienol intake may be associated with improved survival and lower recurrence in patients with early breast cancer.

Conclusion

The study found no significant association between tocotrienol therapy and breast cancer-specific survival in women with early breast cancer.

Supporting Evidence

  • Five-year breast cancer-specific survival was 98.3% in the intervention group and 95% in the control group.
  • The risk of mortality due to breast cancer was 60% lower in the intervention group, but this was not statistically significant.
  • The study had complete follow-up of all patients who complied with their treatment.

Takeaway

This study looked at whether a vitamin called tocotrienol helps women with early breast cancer live longer when taken with another medicine called tamoxifen, but it didn't find strong evidence that it does.

Methodology

A double-blinded, placebo-controlled pilot trial was conducted over 5 years with 240 women assigned to receive either tocotrienol-rich fraction plus tamoxifen or placebo plus tamoxifen.

Potential Biases

Nonrandom assignment of participants may introduce bias.

Limitations

The study lacked randomization and had a relatively small sample size with low outcomes, which may limit the ability to detect significant differences.

Participant Demographics

Women aged 40 to 60 years with early breast cancer and estrogen receptor-positive tumors.

Statistical Information

P-Value

0.27

Confidence Interval

95% CI, 0.08 to 2.05

Digital Object Identifier (DOI)

10.1186/bcr2726

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