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Sponsors and Collaborators: |
Centre hospitalier universitaire de Québec The Cancer Research Society |
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Information provided by: | Centre hospitalier universitaire de Québec |
ClinicalTrials.gov Identifier: | NCT00721890 |
Green tea is extracted from steam treated leaves, allowing the preservation of catechins, the active elements of the infusion. Catechins are recognized for their anti-cancer activity. Catechins act on the capacity of cancer to disseminate to other organs because of their anti-protease action. Proteases are proteins capable of digesting the cancer environment and facilitating the progression of cancer cells to blood vessels which will bring them to distant organs. We know that ovarian cancer responds well to the initial treatment of chemotherapy but tends to recur rapidly. We intend to provide green tea with higher concentrations of catechins to women with complete remission of their ovarian cancer in an attempt to delay cancer relapse. We also intend to identify, with molecular technologies, the proteases involved in ovarian cancer recurrence and response to catechins. Our objective is to test the hypothesis that green tea intake may delay ovarian cancer recurrence and to develop tools to predict which women will best benefit of the addition of green tea to their initial treatment.
Condition | Intervention | Phase |
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Ovarian Carcinoma |
Dietary Supplement: Double-Brewed Green Tea |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma |
Estimated Enrollment: | 42 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Dietary Supplement: Double-Brewed Green Tea
liquid, 4 celsius; 500 mL ID, 3 hours after meals and 1 hour before next meal; duration: to the first of the following events: 18 months or relapse
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bernard Têtu, MD | 418-691-5233 | bernard.tetu@chuq.qc.ca |
Contact: Isabelle Bairati, MD | 418-525-4444 ext 15569 | isabelle.bairati@chuq.qc.ca |
Canada, Quebec | |
Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec | Recruiting |
Québec, Quebec, Canada, G1R 2J6 | |
Principal Investigator: Bernard Têtu, MD |
Principal Investigator: | Bernard Têtu, MD | Université Laval |
Principal Investigator: | Isabelle Bairati, MD | Université Laval |
Study Chair: | Marie Plante, MD | Université Laval |
Study Chair: | Laurent Bazinet, PhD | Université Laval |
Study Chair: | Dimcho Bachvarov, PhD | Université Laval |
Responsible Party: | Université Laval ( Bernard Têtu ) |
Study ID Numbers: | SC-126639 |
Study First Received: | July 23, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00721890 |
Health Authority: | Canada: Health Canada |
chemoprevention green tea relapse free-survival proteases |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian epithelial cancer Carcinoma Genital Diseases, Female Endocrinopathy Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Adnexal Diseases |