Prospective Single-arm Trial of Fluconazole for Preventing Chemoradiation-associated Oral Mucositis in Head and Neck Cancer

Phase 2

• Conditions: stomatitis; oral mucositis

• Registration Number: JPRN-jRCTs031190265
• Lead Sponsor: Saito Hirotake

Brief Summary

Terminated due to retirement of research physician.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-01
• Study Completion: 2021-01-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

histologically proven localized head and neck squamous cell carcinoma
no distant metastases
no active concomitant malignancy
being capable of oral intake
adequate function of bone marrow, liver, and kidneys

Exclusion Criteria

receiving drugs that is not allowed to take with fluconazole at the same time
history of drug hypersensitivity
history of head and neck irradiation
active infectious disease
severe cardiopulmonary comorbidities
incapable of consent to study due to neuropsychological causes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe oral mucositis, defined by WHO Grade 3,4

Secondary Outcome Measures

Name	Time	Method
daily opioid doses<br>mouth and throat soreness score<br>interruption or early cessation of treatment<br>maximum of ALT, AST,g-GTP,total bilirubin<br>adverse events