Fluconazole for oral mucositis prophylaxis in head and neck cancer treated with concurrent chemoradiotherapy

Phase 2

Completed

• Conditions: head and neck cancer treated with definitive or postoperative radiation therapy with concurrent chemotherapy; Oral mucositis prophylaxis

• Registration Number: TCTR20210326005
• Lead Sponsor: Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-26
• Study Completion: 2022-05-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1.Patient with head and neck cancer receiving either definitive or post-operative radiotherapy (intensity-modulated radiotherapy or three-dimensional conformal radiotherapy) concurrent with chemotherapy.
2.Age 18 - 70 years old
3.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4.Basic Laboratories within normal limit (CBC, BUN/Cr, LFT)
5.Signing of informed consent

Exclusion Criteria

1.Patients with sign and symptom of oral candidiasis at the screening
2.Patients with previous history of head and neck radiotherapy
3.Patient planned with palliative RT
4.Patients with severe allergy or hypersensitivity to fluconazole
5.Patients with severe hepatic transaminases and CKD stage V
6.Patients whose current medication(s) has severe interaction with fluconazole e.g., cyclosporine, tacrolimus, sirolimus, prednisone, methylprednisolone, midazolam, phenytoin, warfarin, nifedipine, statins drug, rifampin.
7.Patients with pregnancy or lactation
8.Patient with systemic fungal infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of severe mucositis weekly during radiotherapy treatment CTCEA version 5

Secondary Outcome Measures

Name	Time	Method
Difference of mean days of radiotherapy treatment daily during the radiotherapy end of radiotherapy,Difference of mean percent weight change at 1st, 4th, and 7th week of radiotherapy between two arms 1st, 4th, and 7th week of radiotherapy treatment mean percent weight ,Difference of mean quantities of Candidiasis spp. using colony-forming units (CFUs) from at 1st, 4th, and 7th week of radiotherapy between two arms 1st, 4th, and 7th week of radiotherapy treatment Candida colony forming unit per ml