Clinical trial NCT00721890: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma
Official title: Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Carcinoma
Keywords: chemoprevention
green tea
relapse free-survival
proteases
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Cancer Research Society
First posted: 2008-07-25
Enrollment: 16
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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.

Primary outcomes:
measure: time to relapse
timeFrame: 36 months
Secondary outcomes:
measure: toxicity
timeFrame: 14th and 28th patients recruted and PRN
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec
state: Quebec
Study officials:
affiliation: Laval University
name: Bernard Têtu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Isabelle Bairati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Marie Plante, MD
role: STUDY_CHAIR
affiliation: Laval University
name: Laurent Bazinet, PhD
role: STUDY_CHAIR
affiliation: Laval University
name: Dimcho Bachvarov, PhD
role: STUDY_CHAIR
References:
citation: 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.