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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190265

Enrollment

Registered

2020-04-01

Start date

2020-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

oral mucositis oral mucositis

Interventions

Administration of Oral Fluconazole 2 capsules a day during chemoradiotherapy.

Fluconazole

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Severe oral mucositis, defined by WHO Grade 3,4	—

Secondary

Measure	Time frame
daily opioid doses mouth and throat soreness score interruption or early cessation of treatment maximum of ALT, AST,g-GTP,total bilirubin adverse events	—

Contacts

Public ContactHirotake Saito

Niigata University Medical and Dental Hospital

1rtkcyte@med.niigata-u.ac.jp+81-25-227-2315

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026