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Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer

Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05633719
Enrollment
300
Registered
2022-12-01
Start date
2022-12-01
Completion date
2026-06-30
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor, Childhood

Keywords

Pediatric solid tumor, Chemotherapy, Hearing loss

Brief summary

More than half of all pediatric cancer in Korea are solid cancer. For the treatment of solid cancer, multidisciplinary methods such as surgery, chemotherapy, and radiation therapy are applied, and with the development of the treatment method, the treatment performance has improved dramatically, and the 5-year survival rate of more than 80% is currently recorded. Due to the improvement in survival rate, interest in side effects caused by cancer treatment itself is gradually increasing, and efforts to reduce them are increasing. Accordingly, it aims to contribute to improving the quality of life of pediatric solid cancer survivors. by developing a Korean-type early diagnosis and follow-up protocol of ototoxic hearing loss, which commonly occurs in pediatric solid cancer who have undergone chemotherapy.

Interventions

OTHERChemotherapy involving cisplatin or carboplatin

Chemotherapy

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No

Inclusion criteria

① Solid cancer patients under the age of 19 receiving Platinum chemotherapy ② Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy

Exclusion criteria

① Those who have received chemotherapy or radiation in the past * Those who have difficulty understanding the clinical trial due to mental retardation or unable to read the consent form, such as illiteracy or foreigners ③ Those who have difficulty in hearing test due to neurological factors, etc. ④ Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with ototoxic hearing loss1 year after the initiation of chemotherapyProportion of patients with ototoxic hearing loss in total patients

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026