Cancer Control Research
 Assessment of Hearing Loss (Ototoxity) in Children Receiving Cisplatin Chemotherapy: A Children’s Oncology Group StudyPrincipal Investigator: David Freyer, D.O. Although cisplatin is an excellent anti-cancer agent, its use is often limited by hearing loss (ototoxicity). There has been great interest in testing agents capable of preventing cisplatin-induced hearing loss without inhibiting the anti-cancer effect of chemotherapy. Previous research aimed at preventing ototoxicity has been limited by uncertainty as to the optimal criteria for determining ototoxicity and uncertainty as to the availability of more sensitive measures of ototoxicity such as ultrahigh frequency (UHF) audiometry and otoacoustic emission (OAE) testing. Furthermore, we have not had a reliable method of measuring ototoxicity across multiple institutions in a cooperative group setting. The goals of this observational study are to (1) determine the optimal criteria for determination of ototoxicity; (2) determine the feasibility of including UHF audiometry and evoked OAE testing as adjunctive measures of ototoxicity in a cooperative group setting; and (3) determine the feasibility of central review of audiometry data in a cooperative group setting.
Recent preclinical and adult clinical studies have demonstrated that sodium thiosulfate (STS) prevents hearing loss without affecting the anti-tumor activity of platinum chemotherapy. The goal of this Phase III study is to evaluate in a randomized, controlled, group wide trial whether STS is an effective and safe means of preventing hearing loss in children receiving cisplatin chemotherapy. |