Efficacy of intratympanic sodium thiosulfate gel injection to preventisplatin-induced ototoxicity: a randomized controlled trial

Phase 3

• Conditions: Cisplatin-induced ototoxicity; Sensorineural hearing loss; Sodium thiosulfate; Cisplatin

• Registration Number: TCTR20240520004
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-20
• Last Update Posted: 19 August 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Age 20 years and above
2. Head and neck cancer patients with confirmed histology
3. Plan to receive high dose cisplatin (> 100 mg mg/m2/cycle) treatment as adjuvant, neoadjuvant or palliative chemotherapy

Exclusion Criteria

1. Nasopharyngeal cancer and others cancer which mass obstructing eustachian tube
2. History of ear disease, head trauma or prior ear surgery
3. Abnormal tympanic membrane or narrow ear canal of any ear
4. Asymmetrical hearing at baseline (definition is the asymmetry between two ears of more than 10 dB at any frequency)
5. Hearing loss at baseline PTA > 55 dB (Moderately severe sensorineural hearing loss)
6. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) to the excipients of the study medications (STS, hyaluronic acid)

Study & Design

• Study Type: Interventional
• Study Design: Not specified