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

Phase 2

Completed

• Conditions: Ovarian Carcinoma
• Interventions: Dietary Supplement: Double-Brewed Green Tea

• Registration Number: NCT00721890
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-25
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-22
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Double-Brewed Green Tea	-

Primary Outcome Measures

Name	Time	Method
time to relapse	36 months

Secondary Outcome Measures

Name	Time	Method
toxicity	14th and 28th patients recruted and PRN

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec; 🇨🇦 Québec, Quebec, Canada