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

Division of Radiation Oncology, Faculty of Medicine, Chiang Mai University0 个研究点目标入组 78 人开始时间: 2021年3月26日最近更新: 2024年8月19日

试验速览

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•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

•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

发起方

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