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10/10/09

National Institute of Health Sponsored Study Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervi

National Institute of Health Sponsored Study Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia


What does Green Tea do?

The possibility of health benefits for green tea has been tossed around the halls of research like a medical football. Some studies says yes some say no and at least one claims that it may even interfere with a cancer drug! A clinical trial has been going on at the University of Arizona to determine what if any value green tea extract may have against cancer. Clinical Trial NIH number NCT00303823 is a randomized phase II trial studying green tea extract to see how well it works (if at all) compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. The cervix is the lower, narrow portion of the uterus (the womb) where it joins with the top end of the vagina.

This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive oral green tea extract (Polyphenon E^®) once daily for 16 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.



    They want to:
  • Assess the effect of green tea extract (Polyphenon E^®) in patients with human papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN 1) in a pre- and post-treatment setting. (Cervical intraepithelial neoplasia (CIN), also known as cervical dysplasia, is the potentially premalignant transformation and abnormal growth (dysplasia) of cells on the surface of the cervix. Most cases of CIN remain stable, or are eliminated by the host's immune system without intervention. However a small percentage of cases progress to become cervical cancer, if left untreated. The major cause of CIN is chronic infection of the cervix with the sexually transmitted HPV)



  • Compare the toxicity of green tea extract vs placebo among patients with CIN 1.
  • Evaluate the utility of karyometry (studying the nucleus of a cell) as an intermediate endpoint biomarker for cervical chemoprevention studies.
    A total of 176 patients will be accrued for this study.
  • Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
  • Green tea polyphenols block the anticancer effects of bortezomib and other boronic acid–based proteasome inhibitors

    "The anticancer potency of green tea and its individual components is being intensely investigated, and some cancer patients already self-medicate with this "miracle herb" in hopes of augmenting the anticancer outcome of their chemotherapy. Bortezomib (BZM) is a proteasome inhibitor in clinical use for multiple myeloma".