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FACT
Focus on Alternative and Complementary Therapies

Trial of Essiac to ascertain its effect in women with breast cancer (TEA-BC)

Boon H1, Zick S2, Green J3, Olatunde S1
1Leslie Dan Faculty of Pharmacy, University of Toronto, Canada
2Michigan Integrative Medicine, University of Michigan, Department of Family Medicine and Comprehensive Cancer Center, USA
3Henry Ford Center for Complementary and Integrative Medicine, USA

Objective

To assess the difference between women who have or are taking Essiac (a blend of at least four herbs) compared to women who have never taken Essiac.

Materials and methods

We conducted a retrospective cohort study in 2500 women with a diagnosis of primary breast cancer between June 30, 2002, and July 31, 2003, randomly chosen from the Ontario Cancer Tumour Registry. Each woman’s physician was contacted to obtain permission to send her a survey and obtain a current mailing address. Surveys will be mailed to all eligible women in June 2005.

Results

The primary result will be to determine the difference in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy Breast Cancer Version (FACT-B) between Essiac users and non-users. Secondary endpoints will include differences in depression, anxiety, global quality of life, fatigue, rate of adverse events and prevalence of complications or benefits during standard breast cancer treatment. Additionally, we will describe the pattern of use (duration, dose, frequency, etc.) of Essiac in this cohort of women.

Conclusion

As a result of this investigation, we will obtain a more comprehensive understanding of the potential role of Essiac in the treatment of breast cancer and the control of breast-cancer-related symptoms. More broadly, we will collect pilot data, which will allow us to determine the feasibility of progressing to phase I and II trials with this natural health product.

Acknowledgement

This study was funded by the Natural Health Products Research Program of Health Canada.

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