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Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma

NCT ID: NCT00721890

Last Updated: 2013-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Carcinoma

Keywords

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chemoprevention green tea relapse free-survival proteases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Double-Brewed Green Tea

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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DBGT

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research Society

OTHER

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Bernard Têtu

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard Têtu, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Isabelle Bairati, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Marie Plante, MD

Role: STUDY_CHAIR

Laval University

Laurent Bazinet, PhD

Role: STUDY_CHAIR

Laval University

Dimcho Bachvarov, PhD

Role: STUDY_CHAIR

Laval University

Locations

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Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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Trudel D, Labbe DP, Araya-Farias M, Doyen A, Bazinet L, Duchesne T, Plante M, Gregoire J, Renaud MC, Bachvarov D, Tetu B, Bairati I. A two-stage, single-arm, phase II study of EGCG-enriched green tea drink as a maintenance therapy in women with advanced stage ovarian cancer. Gynecol Oncol. 2013 Nov;131(2):357-61. doi: 10.1016/j.ygyno.2013.08.019. Epub 2013 Aug 27.

Reference Type DERIVED
PMID: 23988418 (View on PubMed)

Other Identifiers

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SC-126639

Identifier Type: -

Identifier Source: org_study_id