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Efficacy and safety of intravenous administration of high-dose selenium for preventing chemotherapy-induced peripheral neuropathy in platinum- sensitive recurrent ovarian, fallopian or primary peritoneal cancer: study protocol for a phase III, double-blind, randomized study

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Author(s)
Soo Jin ParkGa Won YimHaerin PaikNara LeeSeungmee LeeMaria LeeHee Seung Kim
Keimyung Author(s)
Lee, Seung Mee
Department
Dept. of Obstetrics & Gynecology (산부인과학)
Journal Title
J Gynecol Oncol
Issued Date
2021
Volume
32
Issue
5
Keyword
SeleniumPlatinum-SensitiveRecurrentOvarian CancerChemotherapyNeuropathy
Abstract
Background:
The second-line chemotherapy using paclitaxel, carboplatin, and bevacizumab for treating platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer frequently cause chemotherapy-induced peripheral neuropathy (CIPN), which is significantly associated with deterioration of quality of life. Despite the potential of some agents to prevent and treat CIPN, and there is still a lack of evidence of the effect. Although selenium has been suggested as an antioxidant candidate to prevent CIPN, there are insufficient data regarding its effect due to its low dose by oral administration. Thus, we hypothesized intravenous administration of high-dose selenium (2,000 µg/day) at each cycle of the second-line chemotherapy would prevent and reduce CIPN in patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer.

Method:
This trial is an investigator-initiated, phase III, double-blinded, randomized controlled trial to evaluate the efficacy and safety of intravenous administration of high-dose selenium (2,000 µg/day) for preventing CIPN in patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer who receive paclitaxel, carboplatin, and bevacizumab. A total of 68 patients will be randomly assigned to the experimental and control groups at a 1:1 ratio. As the primary endpoint, the incidence rate of CIPN three months after six cycles of chemotherapy will be compared between the two groups according to the combined criteria of neuropathy using the World Health Organization-CIPN criteria and Common Terminology Criteria for Adverse Events version 5.0. As secondary endpoints, we will compare adverse events, patient-reported quality of life, and requirement of concomitant drugs for reducing CIPN between the two groups.
Keimyung Author(s)(Kor)
이승미
Publisher
School of Medicine (의과대학)
Citation
Soo Jin Park et al. (2021). Efficacy and safety of intravenous administration of high-dose selenium for preventing chemotherapy-induced peripheral neuropathy in platinum- sensitive recurrent ovarian, fallopian or primary peritoneal cancer: study protocol for a phase III, double-blind, randomized study. J Gynecol Oncol, 32(5), e73. doi: 10.3802/jgo.2021.32.e73
Type
Article
ISSN
2005-0399
Source
https://m.ejgo.org/search.php?where=aview&id=10.3802/jgo.2021.32.e73&code=1114JGO&vmode=FULL
DOI
10.3802/jgo.2021.32.e73
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43766
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Obstetrics & Gynecology (산부인과학)
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