High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chemotherapy Induced Peripheral Neuropathy
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Carcinoma
- Recurrent Ovarian Carcinoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients enrolled in this study will be randomized into two groups. Patients in the control group will receive paclitaxel chemotherapy every 3 weeks for a total of 6 cycles and a dose of normal saline 40 ml every cycle before chemotherapy begins. Patients in the experimental group will receive a dose of selenium 2000 ?g/40 ml instead every cycle before chemotherapy.Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 19 years and 80 years
- Gender
- Only males
Description
High-dose selenium is known to reduce systemic inflammatory responses through antioxidant and anti-inflammatory effects. Selenium has also been shown in pre-clinical studies to inhibit chemotherapy-induced peripheral neuropathy through reactive oxygen species mechanisms in cells. Therefore, the inve...
High-dose selenium is known to reduce systemic inflammatory responses through antioxidant and anti-inflammatory effects. Selenium has also been shown in pre-clinical studies to inhibit chemotherapy-induced peripheral neuropathy through reactive oxygen species mechanisms in cells. Therefore, the investigators aimed to confirm the effect of preventing high dose intravenous selenium prior to chemotherapy and to prevent neuropathy caused by chemotherapy. In this study, the investigators will identify the frequency and severity of CIPN according to World Health Organization (WHO) criteria. Also, the investigators will assess the patient's quality of life (QoL), evaluate the effects of the administration of inorganic selenium on CIPN and QoL, and confirm the safety of high-dose selenium. I would like to.
Tracking Information
- NCT #
- NCT04201561
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Investigators
- Principal Investigator: Hee Seung Kim, MD/PhD Seoul National University Hospital
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