Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma (DBGT-OC-CR)

This study has been completed.
Sponsor:
Collaborator:
The Cancer Research Society
Information provided by (Responsible Party):
Bernard Têtu, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT00721890
First received: July 23, 2008
Last updated: October 22, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU 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 ]

Enrollment: 16
Study Start Date: June 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Other Name: DBGT

  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

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU 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

No publications provided by Centre Hospitalier Universitaire de Québec, CHU de Québec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernard Têtu, Professor, MD, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT00721890     History of Changes
Other Study ID Numbers: SC-126639
Study First Received: July 23, 2008
Last Updated: October 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
chemoprevention
green tea
relapse free-survival
proteases

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 23, 2014