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

Not yet recruiting

• Conditions: Solid Tumor, Childhood
• Interventions: Other: Chemotherapy involving cisplatin or carboplatin

• Registration Number: NCT05633719
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study Start: 2022-12-01
• Study First Posted: 2022-12-01
• Last Update Posted: 2022-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric solid cancer	Chemotherapy involving cisplatin or carboplatin	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with ototoxic hearing loss	1 year after the initiation of chemotherapy	Proportion of patients with ototoxic hearing loss in total patients