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IRCT20211202053252N2 IRCT 2024-08-18 Babol University of Medical Sciences SIlymarin vs BEnzydamine in Radiation-Induced orophAryngeal mucositis SIBERIA A comparison of silymarin vs benzydamine rinse in the prevention of radiation-induced oropharyngeal mucositis in head and neck cancers: A randomized controlled trial 2024-08-31 anticipated 98 Complete https://irct.ir/trial/78360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Permuted block randomization with a block size of 4 individual was carried out on Sealed Envelope website (www.sealedenvelope.com) and its Excel output file with three letter codes is only available to the study pharmacist who is based outside the hospital and is completely separate from the study process. Patients are stratified in terms of receiving/not receiving concurrent chemotherapy. The pharmacist of the study prepares the silymarin and benzydamine mouthwashes, which are completely similar in terms of color, smell, taste and consistency, and packs them into completely similar colorless 250 cc graduated bottles and sticks the three-letter codes on the bottles of treatment arms: A (silymarin ) and B (benzidamine). Next, the codes assigned to the strata (chemotherapy and no-chemotherapy) are printed with consecutive numbers (from 1 to 49 for each strata) and provided to the principal investigator. After determining the treatment plan by the treating physician, eligible patients are referred to the principal investigator. Following acceptance of the study conditions and signing the informed consent form, they will receive their drug with the dedicated strata bottle code in sequence (i.e. from 1 to 49). Each patient receives a total of 10 bottles with the same code; one or two bottles delivered each week, Blinding description: The three letter codes assigned to each strata (chemotherapy and no-chemotherapy) are printed with consecutive numbers (from 1 to 49 for each strata) and provided to the principal investigator, which in turn prints out each number with it's unique three letter code on a discrete paper. Then papers are enveloped and numbered from 1 to 49. Eligible patients in each strata are sequentially provided bottles starting from number 1 by admission order. The corresponding codes for each patient is recorded and delivered to the pharmacist on a weekly basis. 3 Malignant neoplasm of head, face and neck. Intervention 1: Silymarin group: Patients Swish mouth with 15 ml of 0.2% silymarin solution (Silybum marianum extract, Zardband pharmaceuticals, Tehran, Iran) every 8 hours for two minutes and spit the remainder. Intervention 2: Benzydamine group: Patients Swish mouth with 15 ml of 0.15% Benzydamine solution (Benzylagine – Exir Pharmaceutical Company, Tehran, Iran) every 8 hours for two minutes and spit the remainder. Yes - There is a plan to make this available What will be shared: All of the deidentified data are to be released after publication of the study When: Within one year after paper publication To whom: Any academic institution can have access to data Conditions: There is no restriction Where to obtain: Any interested institution is expected to send a formal email to the Health Research Institute of Babol University of Medical Sciences. Email: hribabol@gmail.com Phone & Fax: +98-11-32190557 Website: hri.mubabol.ac.ir How to obtain: The documents would be delivered to the applicant by email, after one business week. In some cases, a Research Vice Chancellor and/or Ethics Committee approval for data access may be needed in which the aforementioned time may stretch up to three weeks. Applicants are not required to do additional tasks in such cases. Comments:
public Davoud Jahansouz
Shilat Sq., Shariati St.
Babolsar Iran (Islamic Republic of) 4741999879 +98 11 3528 9260 d-jahansouz@alumnus.tums.ac.ir Babol University of Medical Sciences scientific Davoud Jahansouz
Shilat Sq., Shariati St.
Babolsar Iran (Islamic Republic of) 4741999879 +98 11 3528 9260 d-jahansouz@alumnus.tums.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Age over 18 years old Any ECOG performance status Head and neck cancer patient Any setting of radiation (i.e. definitive, neoadjuvant, adjuvant) Receiving at least 50 Gy radiation to 2 out of 4 subsite of the head and neck, including oral cavity, Oropharynx, hypopharynx, and the larynx More than 2 cm of irradiated mucosal surface in any head and neck subsite 18 years no limit Both 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 C76.0 Malignant neoplasm of head, face and neck Treatment - Drugs Treatment - Drugs Silymarin group: Patients Swish mouth with 15 ml of 0.2% silymarin solution (Silybum marianum extract, Zardband pharmaceuticals, Tehran, Iran) every 8 hours for two minutes and spit the remainder. Benzydamine group: Patients Swish mouth with 15 ml of 0.15% Benzydamine solution (Benzylagine – Exir Pharmaceutical Company, Tehran, Iran) every 8 hours for two minutes and spit the remainder. Grade 3 mucositis. Timepoint: Before intervention and every week after intervention for at least 5 weeks. Method of measurement: According to CTCAE v.5. Grade 1 and 2 mucositis. Timepoint: before intervention and every week during intervention for at least 5 weeks. Method of measurement: According to CTCAE v.5. Grade 3 and 4 mucositis. Timepoint: before intervention and every week during intervention for at least 5 weeks. Method of measurement: According to CTCAE v.5. Mucositis onset. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: The day of the first evidence of grade 1 mucositis detected by history or examination from the day of treatment initiation - according to CTCAE v.5. Tube or Intravenous nutrition. Timepoint: Before intervention and every week during intervention for at least 5 weeks. Method of measurement: History and examination. Opioid Use. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: Any opioid use detected by subjectively. Hospitalization. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: Subjective - Inquired. Mucositis recovery time. Timepoint: Every week during intervention for at least 5 weeks, and the two post-intervention weeks. Method of measurement: The day mucositis score reaches zero from treatment termination - according to CTCAE v5.0. Mortality. Timepoint: Every week during intervention for at least 5 weeks. Method of measurement: Subjective - Inquired. Overall survival. Timepoint: The duration of survival after 24 months (730 days) from the moment of randomization. Method of measurement: Subjective - Inquired. Babol University of Medical Sciences Approved 2024-08-11 Health Research Center, Babol University of Medical Sciences Daneshagh Sq. Babol Mazandaran Iran (Islamic Republic of)