Open AccessPrevention of cisplatin‐induced hearing loss in children: Informing the design of future clinical trials
Author(s) -
Minasian Lori M.,
Frazier A. Lindsay,
Sung Lillian,
O’Mara Ann,
Kelaghan Joseph,
Chang Kay W.,
Krailo Mark,
Pollock Brad H.,
Reaman Gregory,
Freyer David R.
Publication year - 2018
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.1563
Subject(s) - clinical trial , medicine , grading (engineering) , clinical study design , hearing loss , psychological intervention , sample size determination , intensive care medicine , risk analysis (engineering) , audiology , engineering , psychiatry , statistics , civil engineering , mathematics
Cisplatin is an essential chemotherapeutic agent in the treatment of many pediatric cancers. Unfortunately, cisplatin‐induced hearing loss ( CIHL ) is a common, clinically significant side effect with life‐long ramifications, particularly for young children. ACCL 05C1 and ACCL 0431 are two recently completed Children’s Oncology Group studies focused on the measurement and prevention of CIHL . The purpose of this paper was to gain insights from ACCL 05C1 and ACCL 0431, the first published cooperative group studies dedicated solely to CIHL , to inform the design of future pediatric otoprotection trials. Use of otoprotective agents is an attractive strategy for preventing CIHL , but their successful development must overcome a unique constellation of methodological challenges related to translating preclinical research into clinical trials that are feasible, evaluate practical interventions, and limit risk. Issues particularly important for children include use of appropriate methods for hearing assessment and CIHL severity grading, and use of trial designs that are well‐informed by preclinical models and suitable for relatively small sample sizes. Increasing interest has made available new funding opportunities for expanding this urgently needed research.