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

October 22, 2013 updated by: Bernard Têtu, CHU de Quebec-Universite Laval

Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • DBGT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to relapse
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
toxicity
Time Frame: 14th and 28th patients recruted and PRN
14th and 28th patients recruted and PRN

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

The Cancer Research Society

Investigators

  • Principal Investigator: Bernard Têtu, MD, Laval University
  • Principal Investigator: Isabelle Bairati, MD, Laval University
  • Study Chair: Marie Plante, MD, Laval University
  • Study Chair: Laurent Bazinet, PhD, Laval University
  • Study Chair: Dimcho Bachvarov, PhD, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (ESTIMATE)

July 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-126639

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe