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Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma (DBGT-OC-CR)
This study is currently recruiting participants.
Verified by Centre hospitalier universitaire de Québec, July 2008
Sponsors and Collaborators: Centre hospitalier universitaire de Québec
The Cancer Research Society
Information provided by: Centre hospitalier universitaire de Québec
ClinicalTrials.gov Identifier: NCT00721890
  Purpose

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
Ovarian Carcinoma
Dietary Supplement: Double-Brewed Green Tea
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
U.S. FDA Resources
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

Further study details as provided by Centre hospitalier universitaire de Québec:

Primary Outcome Measures:
  • time to relapse [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: 14th and 28th patients recruted and PRN ] [ Designated as safety issue: Yes ]

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
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with ovarian serous carcinoma FIGO stage III or IV
  • patients showing complete response after oncological surgery and chemotherapy (paclitaxel-carboplatin, minimum 5 cycles, maximum 8 cycles), complete response being defined as 1) a negative complete physical examination 2) Serum CA-125 levels inferior to 35 U/mL 3) no evidence of diseased assessed by abdomino-perineal CT-scan
  • patients refraining from drinking tea other than provided by the study
  • patients who may absorb liquids orally
  • patients without any other malignancy (except for non-melanoma skin cancer)
  • patients not involved in an other study
  • patients who signed up informed consent form.

Exclusion Criteria:

  • exclusion criteria are implicit from inclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721890

Contacts
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

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec Recruiting
Québec, Quebec, Canada, G1R 2J6
Principal Investigator: Bernard Têtu, MD            
Sponsors and Collaborators
Centre hospitalier universitaire de Québec
The Cancer Research Society
Investigators
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
  More Information

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

Keywords provided by Centre hospitalier universitaire de Québec:
chemoprevention
green tea
relapse free-survival
proteases

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009