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

Solid Tumor, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05633719
• Other study ID #: 2208-162-1354
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 30, 2026
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

Inclusion Criteria:

? Solid cancer patients under the age of 19 receiving Platinum chemotherapy

? Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy

Exclusion Criteria:

? 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 ? Those who have difficulty in hearing test due to neurological factors, etc. ? Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Solid Tumor, Childhood

Intervention

Other:
• Chemotherapy involving cisplatin or carboplatin
Chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with ototoxic hearing loss	Proportion of patients with ototoxic hearing loss in total patients	1 year after the initiation of chemotherapy