A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study
BackgroundSome children with central nervous system (CNS) and solid tumors are at risk to develop ototoxicity during treatment. Up to now, several risk factors have been identified that may contribute to ototoxicity, such as platinum derivates, cranial irradiation, and brain...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2022-04-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2022/4/e34297 |
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| author | Franciscus A Diepstraten Annelot JM Meijer Martine van Grotel Sabine LA Plasschaert Alexander E Hoetink Marta Fiocco Geert O Janssens Robert J Stokroos Marry M van den Heuvel-Eibrink |
| author_facet | Franciscus A Diepstraten Annelot JM Meijer Martine van Grotel Sabine LA Plasschaert Alexander E Hoetink Marta Fiocco Geert O Janssens Robert J Stokroos Marry M van den Heuvel-Eibrink |
| author_sort | Franciscus A Diepstraten |
| collection | DOAJ |
| description |
BackgroundSome children with central nervous system (CNS) and solid tumors are at risk to develop ototoxicity during treatment. Up to now, several risk factors have been identified that may contribute to ototoxicity, such as platinum derivates, cranial irradiation, and brain surgery. Comedication, like antibiotics and diuretics, is known to enhance ototoxicity, but their independent influence has not been investigated in childhood cancer patients. Recommendations for hearing loss screening are missing or vary highly across treatment protocols. Additionally, adherence to existing screening guidelines is not always optimal. Currently, knowledge is lacking on the prevalence of ototoxicity.
ObjectiveThe aim of the Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND) is to determine the feasibility of audiological testing and to determine the prevalence and determinants of ototoxicity during treatment for childhood cancer in a national cohort of patients with solid and CNS tumors.
MethodsThe SOUND study is a prospective cohort study in the national childhood cancer center in the Netherlands. The study aims to include all children aged 0 to 19 years with a newly diagnosed CNS or solid tumor. Part of these patients will get audiological examination as part of their standard of care (stratum 1). Patients in which audiological examination is not the standard of care will be invited for inclusion in stratum 2. Age-dependent audiological assessments will be pursued before the start of treatment and within 3 months after the end of treatment. Apart from hearing loss, we will investigate the feasibility to screen patients for tinnitus and vertigo prevalence after cancer treatment. This study will also determine the independent contribution of antibiotics and diuretics on ototoxicity.
ResultsThis study was approved by the Medical Research Ethics Committee Utrecht (Identifier 20-417/M). Currently, we are in the process of recruitment for this study.
ConclusionsThe SOUND study will raise awareness about the presence of ototoxicity during the treatment of children with CNS or solid tumors. It will give insight into the prevalence and independent clinical and cotreatment-related determinants of ototoxicity. This is important for the identification of future high-risk patients. Thereby, the study will provide a basis for the selection of patients who will benefit from innovative otoprotective intervention trials during childhood cancer treatment that are currently being prepared.
Trial RegistrationNetherlands Trial Register NL8881; https://www.trialregister.nl/trial/8881
International Registered Report Identifier (IRRID)DERR1-10.2196/34297 |
| first_indexed | 2024-03-12T12:54:47Z |
| format | Article |
| id | doaj.art-a255b2391f3041c9aea5e7314d1e668f |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:54:47Z |
| publishDate | 2022-04-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-a255b2391f3041c9aea5e7314d1e668f2023-08-28T21:21:00ZengJMIR PublicationsJMIR Research Protocols1929-07482022-04-01114e3429710.2196/34297A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective StudyFranciscus A Diepstratenhttps://orcid.org/0000-0002-2507-1820Annelot JM Meijerhttps://orcid.org/0000-0003-1631-0006Martine van Grotelhttps://orcid.org/0000-0002-8849-8573Sabine LA Plasschaerthttps://orcid.org/0000-0003-3391-3618Alexander E Hoetinkhttps://orcid.org/0000-0002-7417-5546Marta Fioccohttps://orcid.org/0000-0001-5588-0277Geert O Janssenshttps://orcid.org/0000-0002-0331-713XRobert J Stokrooshttps://orcid.org/0000-0001-8037-2573Marry M van den Heuvel-Eibrinkhttps://orcid.org/0000-0002-7760-879X BackgroundSome children with central nervous system (CNS) and solid tumors are at risk to develop ototoxicity during treatment. Up to now, several risk factors have been identified that may contribute to ototoxicity, such as platinum derivates, cranial irradiation, and brain surgery. Comedication, like antibiotics and diuretics, is known to enhance ototoxicity, but their independent influence has not been investigated in childhood cancer patients. Recommendations for hearing loss screening are missing or vary highly across treatment protocols. Additionally, adherence to existing screening guidelines is not always optimal. Currently, knowledge is lacking on the prevalence of ototoxicity. ObjectiveThe aim of the Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND) is to determine the feasibility of audiological testing and to determine the prevalence and determinants of ototoxicity during treatment for childhood cancer in a national cohort of patients with solid and CNS tumors. MethodsThe SOUND study is a prospective cohort study in the national childhood cancer center in the Netherlands. The study aims to include all children aged 0 to 19 years with a newly diagnosed CNS or solid tumor. Part of these patients will get audiological examination as part of their standard of care (stratum 1). Patients in which audiological examination is not the standard of care will be invited for inclusion in stratum 2. Age-dependent audiological assessments will be pursued before the start of treatment and within 3 months after the end of treatment. Apart from hearing loss, we will investigate the feasibility to screen patients for tinnitus and vertigo prevalence after cancer treatment. This study will also determine the independent contribution of antibiotics and diuretics on ototoxicity. ResultsThis study was approved by the Medical Research Ethics Committee Utrecht (Identifier 20-417/M). Currently, we are in the process of recruitment for this study. ConclusionsThe SOUND study will raise awareness about the presence of ototoxicity during the treatment of children with CNS or solid tumors. It will give insight into the prevalence and independent clinical and cotreatment-related determinants of ototoxicity. This is important for the identification of future high-risk patients. Thereby, the study will provide a basis for the selection of patients who will benefit from innovative otoprotective intervention trials during childhood cancer treatment that are currently being prepared. Trial RegistrationNetherlands Trial Register NL8881; https://www.trialregister.nl/trial/8881 International Registered Report Identifier (IRRID)DERR1-10.2196/34297https://www.researchprotocols.org/2022/4/e34297 |
| spellingShingle | Franciscus A Diepstraten Annelot JM Meijer Martine van Grotel Sabine LA Plasschaert Alexander E Hoetink Marta Fiocco Geert O Janssens Robert J Stokroos Marry M van den Heuvel-Eibrink A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study JMIR Research Protocols |
| title | A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study |
| title_full | A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study |
| title_fullStr | A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study |
| title_full_unstemmed | A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study |
| title_short | A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study |
| title_sort | study on prevalence and determinants of ototoxicity during treatment of childhood cancer sound protocol for a prospective study |
| url | https://www.researchprotocols.org/2022/4/e34297 |
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