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

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ClinicalTrials.gov Identifier: NCT00721890
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : October 24, 2013
Sponsor:
Collaborator:
The Cancer Research Society
Information provided by (Responsible Party):
Bernard Têtu, CHU de Quebec-Universite Laval

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Carcinoma Dietary Supplement: Double-Brewed Green Tea Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma
Study Start Date : June 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013


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 Name: DBGT




Primary Outcome Measures :
  1. time to relapse [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. toxicity [ Time Frame: 14th and 28th patients recruted and PRN ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721890


Locations
Canada, Quebec
Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 2J6
Sponsors and Collaborators
CHU de Quebec-Universite Laval
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernard Têtu, Professor, MD, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT00721890     History of Changes
Other Study ID Numbers: SC-126639
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013

Keywords provided by Bernard Têtu, CHU de Quebec-Universite Laval:
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