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

Ovarian Carcinoma Clinical Trial

— DBGT-OC-CR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721890
• Other study ID #: SC-126639
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2008
• Last updated: October 22, 2013
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Glandular and Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	The Cancer Research Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to relapse		36 months	Yes
Secondary	toxicity		14th and 28th patients recruted and PRN	Yes