An open randomized controlled clinical trial to evaluate the efficacy of a maintenance therapy with supplements containing I3C and EGCG in ovarian cancer patients

Russian Scientific Center of Roentgenoradiology0 sites284 target enrollmentMarch 24, 2016

Overview

No summary available.

Registry

who.int

Start Date

March 24, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

Russian Scientific Center of Roentgenoradiology

•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

•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