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

Fluconazole for oral mucositis prophylaxis in head and neck cancer treated with concurrent chemoradiotherapy: prospective double-blinded, randomized, controlled, intervention, superiority trial with 2 parallel arms

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210326005

Enrollment

Registered

2021-03-26

Start date

2021-07-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Patient in fluconazole prophylaxis arm will receive 100 mg of fluconazole prepared in capsule and take 1 capsule per day starting with radiotherapy and continue until the end of radiotherapy course (a

Experimental Drug,Placebo Comparator Drug

Fluconazole prophylaxis,placebo prophylaxis

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Proportion of severe mucositis weekly during radiotherapy treatment CTCEA version 5	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Thailand

Contacts

Public ContactWaranyu Ueangphairot

Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University

waranyu_tae@hotmail.com053935450

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026