Efficacy of a maintenance therapy with supplements containing indole-3-carbinol (I3C) and epigallocatechin-3-gallate (EGCG) in ovarian cancer patients

Completed

• Conditions: Ovarian cancer; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12616000394448
• Lead Sponsor: Russian Scientific Center of Roentgenoradiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 284

Inclusion Criteria

1) diagnosis of histologically confirmed International Federation Gynecology Obstetrics (FIGO) stage III serous ovarian cancer
2) patients with a general condition corresponding to WHO 0-2
3) absolute granulocyte count >= 1.5 x 10^3/mm^3; platelets >= 100 x 10^3/mm^3
4) adequate liver and renal function (bilirubin, creatinine within normal limits; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.0 times upper normal limit;
AST and ALT must be < 5.0 times upper normal limit if liver metastases present)
5) absence of significant coexisting diseases (documented history of gastric/duodenal ulcer within last 12 months, polyneuropathy, decompensated diabetes, heart attack within 1 year ago)
6) written informed consent

Exclusion Criteria

1) point mutations in the BRCA genes
2) malignant tumors of other localizations
3) positive RW or HIV tests, alcohol or drug abuse
4) pregnancy or lactation
5) organizational problems which could impair the ability to commit treatment and monitoring (remote accommodation etc.)
6) psychiatric illness or uncontrolled psychiatric condition which may hamper compliance with the trial protocol
7) severe coexisting disease which may, in the opinion of the investigator influence the patient's ability to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival defined as the interval between date of diagnosis to the date of death[5 years post standard treatment commencement]

Secondary Outcome Measures

Name	Time	Method
Progression-free survival defined as the earliest disease progression per clinical progression, RECIST, CA-125 progression, or death. CA-125 determination and ultrasonography (US) were conducted every month. Tomographic studies were conducted every 3-4 months. [5 years post standard treatment commencement];Rate of patients with recurrent ovarian cancer with ascite formation. Detection of ascite formation has been defined by US, tomographic studies, and intraoperative findings.[5 years post standard treatment commencement]