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

NCT00721890 | Completed Phase 2 DMC

• 1 other identifier: SC-126639
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Carcinoma

Keywords

chemoprevention; green tea; relapse free-survival; proteases

Outcome Measures

Primary Outcomes (1)

• time to relapse

  36 months

Secondary Outcomes (1)

• toxicity

  14th and 28th patients recruted and PRN

Study Arms (1)

1

EXPERIMENTAL

Dietary Supplement: Double-Brewed Green Tea

Interventions

Double-Brewed Green Tea DIETARY_SUPPLEMENT

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

Also known as: DBGT

1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Cancer Research Society: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Québec, Hôtel-Dieu de Québec

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 23988418 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Bernard Têtu, MD

  Laval University

  PRINCIPAL INVESTIGATOR

• Isabelle Bairati, MD

  Laval University

  PRINCIPAL INVESTIGATOR

• Marie Plante, MD

  Laval University

  STUDY CHAIR

• Laurent Bazinet, PhD

  Laval University

  STUDY CHAIR

• Dimcho Bachvarov, PhD

  Laval University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

CA (1)