Overview

High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy

Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
This study aims to evaluate the safety and efficacy of high dose inorganic selenium in preventing and relieving chemotherapy-induced peripheral neuropathy (CIPN) in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients. This study will be conducted as a phase III randomized controlled trial in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients who are expected to undergo paclitaxel-carboplatin chemotherapy. A total of 68 patients need to be enrolled in this study. The primary objective of this study is to evaluate the frequency of chemotherapy-induced peripheral neuropathy. The secondary objectives are the evaluation of the severity of peripheral neuropathy and the quality of life to show that selenium is effective in preventing and relieving peripheral neuropathy induced by paclitaxel. Positive results in this study will lead to further studies investigating the effect of selenium on other chemotherapies that can induce peripheral neuropathy.
Phase:
Phase 3
Details
Lead Sponsor:
Seoul National University Hospital
Collaborator:
Boryung Pharmaceutical Co., Ltd
Treatments:
Bevacizumab
Carboplatin
Paclitaxel
Selenious Acid
Selenium
Sodium Selenite