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

NCT05633719 | Not Yet Recruiting

• 1 other identifier: 2208-162-1354
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor, Childhood

Keywords

Pediatric solid tumor, Chemotherapy, Hearing loss

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with ototoxic hearing loss

  Proportion of patients with ototoxic hearing loss in total patients

  1 year after the initiation of chemotherapy

Study Arms (1)

Pediatric solid cancer

Other: Chemotherapy involving cisplatin or carboplatin

Interventions

Chemotherapy involving cisplatin or carboplatin OTHER

Chemotherapy

Pediatric solid cancer

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed as solid cancer and receive platinum chemotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Hearing Loss

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 1, 2022

Record last verified: 2022-11