High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy

PHASE3UnknownINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

December 24, 2019

Primary Completion Date

April 30, 2023

Study Completion Date

December 31, 2024

Conditions
Chemotherapy-induced Peripheral NeuropathyRecurrent Ovarian CarcinomaOvarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
Interventions
DRUG

sodium selenite pentahydrate

High-dose inorganic selenium (2000 μg/40 ml) will be administered before chemotherapy in patients assigned to the experimental group.

DRUG

Normal saline

Normal saline (40 ml) will be administered before chemotherapy in patients assigned to the control group.

DRUG

Chemotherapy

Paclitaxel (175mg/m2), carboplatin (AUC 5.0 or 6.0) IV, and bevacizumab IV (15mg/kg) D1, every three weeks.

Trial Locations (1)

03080

Seoul National University Hospital, Seoul

Sponsors
All Listed Sponsors
collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

lead

Seoul National University Hospital

OTHER