Evaluation of the efficacy of nanomisel curcumin in preventing and treating oral candidiasis of patients undergoing head and neck radiation therapy

Determination of the effect of nanomisel curcumin in preventing and treating oral candidiasis of patients undergoing head and neck radiation therapy

A randomized, double blinded, clinical trial(phase III) for 40 patients has been designed. Randomization is performed using a computer-generated random number table.

This double-blind randomized clinical trial is conducted at Mashhad Dental School, Iran. Participants and care providers and assessing outcomes and the statistician are blinded to the type of drug because drugs are placed in similar seal envelope packs.

Inclusion criteria: the minimum age of 18 years, presence of head and neck cancer, radiation dose of 50-70 Gy, at least 50% of patient’s oral cavity in the field of radiation and patient satisfaction. Exclusion criteria included: previous history of radiation therapy, patient dissatisfaction, history of allergy to turmeric, , in case of any oral lesions or complication resulting from radiation therapy other than candidiasis and mucositis, use of systemic or topical antifungal drugs for any reason, pregnancy or breastfeeding periods in women under treatment, presence of local and systemic conditions predisposing for candidiasis, such as the application of inhaled and topical steroids, presence of hyperkeratosis, use of immunosuppressive drugs, history of systemic antibiotic usage over the previous 2 weeks, the presence of CFU above 400/ml in the first culture or clinical evidence based on the presence of oral candidiasis.

The study group: nanocurcumin soft gel (containing 80 mg curcumin) are administrated orally once daily. The control group: placebo tablets areadministrated orally once daily.

Frequency of oral candidiasis

In this study, patients are randomly divided into two groups, namely the Study and Control groups. Randomization is performed using a computer-generated random number table.

In this study, the prepared medicine packs are the same for the two groups. Packages are coded from 1 to 40 by an individual outside the study. Packages are randomly delivered to patients. The participants and care providers and assessing outcomes and statistician are blinded to type of drug.

Some data including demographic properties, signs and symptoms

Two months after article publication.

Academic researchers

It is permitted to use the data in other studies with reference.

Dr.Sedigheh Modarres Mousavy, ModarresMS921@mums.ac.ir

Sending email to authors. the authors will send data via email during 4 weeks