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IRCT20180722040556N12 IRCT 2026-06-03 Esfahan University of Medical Sciences The effect of sildenafil mouthwash on radiotherapy-induced mucositis Evaluation of the Protective and Therapeutic Effects of Sildenafil Citrate Mouthwash on the Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial 2026-06-22 anticipated 36 Recruiting https://irct.ir/trial/90223 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done based on block randomization method. The sampling method is to enter information such as the number of treatment groups, block size (multiple of the number of groups) and the total number of patients in the Internet software for this calculation, and according to the codes that are analyzed The final result is determined, the type of medication received by each patient is determined. In this study, considering that the number of treatment groups was 2 groups, 8 blocks (multiples of 2) are used. The predicted sample size of patients using this sampling method is completely randomly divided into two groups: control users and the main drug user, Blinding description: After preparing the most suitable formulation prepared by a pharmacy student under the supervision of a colleague from the Pharmaceutics group, a placebo similar to the main mouthwash (water solvent with preservative and flavoring) is also prepared and given to the main researcher. The amount of volume predicted for the patient's need for one week (60 ml daily) in glass packages with a code determining the placebo or drug of the product that only the main researcher knows about, will be given to the pharmacy student who collects the information and finally to the patient. 3 Head and Neck Cancer. Intervention 1: Intervention group: Patients with head and neck cancer gargle 20 ml of sildenafil mouthwash three times a day from the first session of radiotherapy and continue to use the mouthwash for the entire course of radiotherapy, which is about 40 days. Some patients develop mouth ulcers (stomata) during radiotherapy sessions, which can be used as part of routine treatments to use the studied mouthwash. Intervention 2: Control group: Control group: They will use a placebo mouthwash completely similar to the sildenafil mouthwash prepared at the Faculty of Pharmacy, gargling 20 ml three times a day and continue using the mouthwash for the entire duration of the radiotherapy treatment, which is about 40 days. If patients develop mouth ulcers (stomatitis) during the radiotherapy sessions, patients will be allowed to use routine treatments (cocktail containing diphenhydramine syrup, aluminum hydroxide, and nystatin drops and chlorhexidine mouthwash) three times a day, 20 ml each time, in addition to taking the placebo. Yes - There is a plan to make this available What will be shared: All collected data When: 6 month after results are published To whom: All academic centers Conditions: All documents with citation Where to obtain: E-mail address How to obtain: After sending a request, we will call the related person and the data will be revealed in less than one week. Comments:
public Azadeh Moghaddas
Hezarjerib
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 7074 moghaddas@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Azadeh Moghaddas
Hezarjerib
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 7074 moghaddas@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Adult patients (18 years and older) Stage 1-4 squamous cell carcinoma, nasopharyngeal carcinoma Patients receiving a total dose of 60 Gy or more in 30 fractions with or without cisplatin Having a maximum performance score of 0 to 2 based on the ECOG Performance Status classification. Patient expected to survive for at least three months. No history of oral and salivary gland diseases before starting radiotherapy. No history of liver and kidney failure Adequate bone marrow function (WBC count above 3000 cells per cubic millimeter of blood) 18 years no limit Both Known hypersensitivity or allergic reaction to sildenafil or any component of the mouthwash formulation Patients taking nitrates (nitroglycerin or isosorbide or similar nitrates) for angina or other heart problems (due to class X drug interactions with sildenafil). Concomitant use of strong CYP3A4 enzyme inhibitors (such as ketoconazole, itraconazole, ritonavir, and clarithromycin, erythromycin) or moderate inhibitors such as the calcium channel blocker family: diltiazem, verapamil, or the antifungal fluconazole, or any drug that has the risk of increasing the plasma concentration of sildenafil (before entering the study, the patient's medication list will be reviewed for clinically important drug interactions. Presence of active oral infection or other inflammatory or ulcerative diseases of the oral mucosa unrelated to radiation therapy (such as aphthous stomatitis and candidiasis). Patients who had a systolic blood pressure of less than 90 mmHg at the initial screening stage or whose blood pressure was identified as less than 90 mmHg during the study were included in the study. Patients taking blood pressure-lowering medications such as beta-blockers or calcium channel blockers, or medications related to cardiovascular disease such as digoxin or amiodarone Patients taking blood pressure-lowering medications such as beta-blockers or calcium channel blockers, or medications related to cardiovascular disease such as digoxin or amiodarone C00-C14 Malignant neoplasm of external lip, unspecified and oral cavity Treatment - Drugs Placebo Intervention group: Patients with head and neck cancer gargle 20 ml of sildenafil mouthwash three times a day from the first session of radiotherapy and continue to use the mouthwash for the entire course of radiotherapy, which is about 40 days. Some patients develop mouth ulcers (stomata) during radiotherapy sessions, which can be used as part of routine treatments to use the studied mouthwash. Control group: Control group: They will use a placebo mouthwash completely similar to the sildenafil mouthwash prepared at the Faculty of Pharmacy, gargling 20 ml three times a day and continue using the mouthwash for the entire duration of the radiotherapy treatment, which is about 40 days. If patients develop mouth ulcers (stomatitis) during the radiotherapy sessions, patients will be allowed to use routine treatments (cocktail containing diphenhydramine syrup, aluminum hydroxide, and nystatin drops and chlorhexidine mouthwash) three times a day, 20 ml each time, in addition to taking the placebo. Severity of oral mucositis caused by radiation therapy. Timepoint: before intervention and then daily until day 7, then twice a week until day 21 after intervention. Method of measurement: NCI -CTCAE version 4.0 Score. Pain intensity due to radiation-induced mucositis. Timepoint: before intervention and then daily until day 7, then twice a week until day 21 after intervention. Method of measurement: Number pain rating scale. The extent of mouth dryness caused by radiation therapy. Timepoint: before intervention and then daily until day 7, then twice a week until day 21 after intervention. Method of measurement: mouth dryness questionnaire (VAS). ًًQuality of life. Timepoint: before intervention and then daily until day 7, then twice a week until day 21 after intervention. Method of measurement: modified Oral Mucositis Daily Questionnaire (modified OMDQ). Side effects of mouthwash. Timepoint: before intervention and then daily until day 7, then twice a week until day 21 after intervention. Method of measurement: PRO-NCI-CTCAE Scale. En Vice-Chancellery for Research of Isfahan University of Medical Sciences Approved 2026-05-12 Ethics committee of isfahan university of medical sciences Isfahan University of medical Scienices, hezar jarib street, Isfahan, Iran isfahan Isfehan Iran (Islamic Republic of)