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

Study Overview
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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.

Official Title
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Phase II Study: Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma

Conditions
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Ovarian Carcinoma

Intervention / Treatment
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* Dietary Supplement: Double-Brewed Green Tea


Participation Criteria
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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. Exclusion Criteria: exclusion criteria are implicit from inclusion criteria.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Double-Brewed Green Tea<br>* 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<br>* Other names: DBGT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to relapse |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  | 14th and 28th patients recruted and PRN | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemoprevention, green tea, relapse free-survival, proteases