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CompletedNCT00721890DBGT-OC-CRUpdated Oct 24, 2013

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

A Phase 2 interventional study of Double-Brewed Green Tea in Ovarian Carcinoma, sponsored by CHU de Quebec-Universite Laval. Completed at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2013-10-24.

Sponsored by CHU de Quebec-Universite Laval · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Sex
Female
01

Study 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.

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Conditions studied

  • Ovarian Carcinoma

Keywords

  • chemoprevention
  • green tea
  • relapse free-survival
  • proteases
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 16 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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:

  • exclusion criteria are implicit from inclusion criteria.
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Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    1

    Dietary Supplement: Double-Brewed Green Tea

Interventions

  • Dietary supplementDouble-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

    Also known as: DBGT

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What researchers measure

Primary outcomes

  1. time to relapse

    Time frame: 36 months

Secondary outcomes

  1. toxicity

    Time frame: 14th and 28th patients recruted and PRN

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec
    Québec, Quebec G1R 2J6, Canada
08

References and documents

Publications

  • 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. PubMed 23988418 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00721890
Lead sponsor
CHU de Quebec-Universite Laval
Collaborators
Cancer Research Society
Responsible party
Bernard Têtu (Professor, MD, CHU de Quebec-Universite Laval) — Principal investigator
First posted
Jul 25, 2008
Start date
Jun 2008
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Oct 24, 2013

Study contacts

Bernard Têtu, MD
principal investigator · Laval University
Isabelle Bairati, MD
principal investigator · Laval University
Marie Plante, MD
study chair · Laval University
Laurent Bazinet, PhD
study chair · Laval University
Dimcho Bachvarov, PhD
study chair · Laval University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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