Phase 1b clinical trial testing whether cimetidine prevents hearing loss from cisplatin chemotherapy in head and neck cancer patients

Phase 1

Recruiting

• Conditions: Chemotherapy toxicity; Cancer - Head and neck; Ear - Deafness; Neurological - Other neurological disorders; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12618000877280
• Lead Sponsor: Associate Professor Michael Jameson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-23
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• pathologically-confirmed locally-advanced HNSCC for which concurrent chemoradiation using cisplatin 100mg/m2 every 3 weeks for 3 cycles is planned
• adequate baseline renal function (estimated glomerular filtration rate >60 ml/min)
• adequate baseline hepatic and bone marrow function;
• have signed written, informed consent

Exclusion Criteria

•planned to receive platinum-based chemotherapy before or after radiation
•prior chemotherapy with cisplatin or platinum analogues
•existing hearing loss > 50 dB between 2000 and 8000 Hz, or hearing aids needed
•radiation treatment plan would result in a cochlear dose > 45 Gy in either ear
•allergic to cimetidine
•taking drugs that are substrates of OCT2 (organic cation transporter type 2) unless the medication can safely be omitted on each day of cisplatin and cimetidine administration
•taking medications with which cimetidine is known to have clinically-significant drug-drug interactions
•congenital or acquired long QT syndrome
•co-morbidities that would preclude cisplatin use, such as cardiac failure
•pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in hearing thresholds (averaged across 4000 Hz and 8000 Hz in both ears) between pretreatment baseline audiogram and an audiogram performed 3 months after completion of chemoradiation[3 months after completion of chemoradiation]