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Study aim: Comparison of the effect of silymarin mouthwash with benzydamine mouthwash in the prevention of grade 3 radiation-induced acute mucositis with doses above 50 Gy in head and neck squamous cell carcinoma until the end of treatment Design: A randomized, parallel group, double-blind phase 3 controlled trial of 98 patients. Randomization was carried using Sealed Envelope website (sealedenvelope.com). Settings and conduct: The study population are head and neck squamous cell carcinoma patients of Shahid Rajaei hospital in Babolsar, who will be treated with head and neck radiotherapy for the first time. The researchers, treating physicians, and the patients are blinded Participants/Inclusion and exclusion criteria: Inclusion Criteria: patients with head and neck squamous cell carcinoma, receiving at least 50 Gy radiation to 2 of the 4 areas of the head and neck including the oral cavity, oropharynx, hypopharynx and larynx Exclusion Criteria: History of severe allergy to silymarin, benzydamine or other NSAIDs, Narcotic use in the last month (even once), History of radiation therapy to the same target areas, Presence of mucositis on admission, History of dry mouth, Proven dementia or history of uncontrolled psychiatric disease, Pregnancy, Malnutrition Intervention groups: Arm A receives Silymarin mouthwash, Arm B receives Benzydamine mouthwash Main outcome variables: Grade 3 mucositis (according to Common Terminology Criteria for Adverse Events (CTCAE) v.5
IRCTID: IRCT20211202053252N2
  1. To evaluate the efficacy and safety of adding metformin to chemoradiation of patients with squamous cell carcinoma of hypopharynx, nasopharynx, and larynx
  2. Comparison of aloe vera mouthwash and and Benzydamine Hydrochloride mouthwash on radiation induced mucositis in patients with head and neck cancer
  3. A comparative study of the effect of black mulberry and honey syrup with benzydamine hydrochloride mouthwash on the prevention of oral mucositis caused by radiation therapy in patients with head and neck cancer
  4. Effects of Sumac spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer
  5. 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
  6. Understanding Compliance, disease control, Survival Rates and Complications in Patients following Hypofractionated Postoperative Radiation Therapy (HYPORT) for Head and Neck Squamous Cell Carcinoma instead of conventional treatment
  7. Evaluation of the effect of Mucosamin in treatment of radiation induced oral cavity mucositis during and after radiotherapy، in patient with oral cavity squamous cell carcinoma (SCC)
  8. Effects of mucutin spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer patients: A comparative clinical study
  9. Complication assessment of concurrent chemoradiotherapy with 100 mg/m2 continuous dose vs 100 mg/m2 divided into three consecutive days in patients with head and neck squamous cell carcinoma , A Randomized clinical trial
  10. A randomized, phase 3, two-armed, parallel group, double blind (patient and outcome assessor blinded), active control, non-inferiority clinical trial to assess the efficacy and safety of Cetuximab bio-similar (Zistdaru Danesh Co. ®) compared to Erbitux (Merck®) in the patients with head and neck squamous cell carcinoma.
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