Incidence of Ototoxicity caused by platinum-based chemotherapy in Thai non-head and Neck irradiated cancerous patients

Phase 4

• Conditions: Ototoxicity; Sensorineural hearing loss; High frequency hearing loss; Toxic labyrinthitis

• Registration Number: TCTR20130922001
• Lead Sponsor: Faculty of Medicine, Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-22
• Study Completion: 2015-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. new case of cancer patients who never receive chemotherapy, Is planned to receive platinum-based chemotherapy and is 20 years old or older.
2. having life expectancy more than 6 months or good performance (Karnofsky score > 60 or ECOG 0-1),
3. having normal liver function test,
4. Having normal GFR or CrCl > 50 ml/min (in case of carboplatin CrCl > 30 ml/min),
5. volunteer to participate

Exclusion Criteria

1. previous head and neck irradiation
2. having external ear disease or middle ear abnormality
3. being diagnosed as Meniere 's disease or Meniere 's syndrome or retrocochlear lesion
4.cannot cooperate with the conventional and ultrahigh frequency audiometry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing loss 6 cycles Utrahigh frequency audiometry

Secondary Outcome Measures

Name	Time	Method
absence emission 6 cycles distortion producted otoacoustic emission