Green Tea Intake for the Maintenance of Complete Remission in Women With Advanced Ovarian Carcinoma (DBGT-OC-CR)

Laval University

Status and phase: Completed; Phase 2

Conditions: Ovarian Carcinoma

Treatments: Dietary Supplement: Double-Brewed Green Tea

Study type: Interventional

Funder types: Other

Identifiers

NCT00721890

SC-126639

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

16 participants in 1 patient group

1

Experimental group

Treatment:

Dietary Supplement: Double-Brewed Green Tea