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IRCT20250928067392N1 IRCT 2025-10-10 Mazandaran University of Medical Sciences Comparison of black mulberry and honey syrup with benzydamine mouthwash in preventing mouth sores caused by radiotherapy in patients with head and neck cance 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 2025-10-23 anticipated 80 Recruiting https://irct.ir/trial/86486 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by a biostatistician. Patients will be assigned into two groups, and the study medications will be distributed by the researcher. Recruitment will be carried out in parallel for both groups with an allocation ratio of 1:1. For randomization, a block randomization method will be used. Accordingly, patients will be numbered consecutively from 1 to 80 upon enrollment. The unit of randomization will be individual patients, and randomization will be performed using blocks of four. The type of group allocation for each patient will be determined using the Random Allocation Software version 2. To generate the random sequence, the software will produce codes “A” and “B,” where code A indicates allocation to the intervention group and code B indicates allocation to the control group. The generated codes will be placed in sealed, opaque envelopes, each labeled with the patient’s serial number. Upon the patient’s entry into the study, the physician will open the corresponding envelope and apply the assigned intervention. Completion of the demographic, clinical symptoms, and medical history forms will be performed by the principal investigator. The contact number of the investigator will be given to participants so that they can report any problems with the medication or their condition. In case a patient does not attend after the treatment period, follow-up will be conducted via telephone by the investigator. 2-3 Radiotherapy-induced oral mucositis. Intervention 1: Intervention group: Patients with head and neck cancer who are candidates for radiotherapy and meet the inclusion criteria will receive the mulberry and honey preparation. The standardized mulberry extract and standardized honey (with necessary approvals such as microbial testing) will be obtained from a reputable company approved by the Food and Drug Administration and will be produced in the form of an oral syrup (manufactured by Giah Kala Company). The dosage will be 5 mL of mulberry-honey syrup per administration, which should be kept in the mouth for 15 seconds and then swallowed. Intervention 2: Control group: Patients with head and neck cancer who are candidates for radiotherapy and meet the inclusion criteria will receive benzydamine hydrochloride mouthwash. The prescribed regimen consists of three daily doses during radiotherapy, with 15 mL per dose, to be kept in the mouth for 30 seconds and then expelled. Yes - There is a plan to make this available What will be shared: Title of documents/data: De-identified patient data (primary and secondary outcomes) Details: Data on oral mucositis severity, pain (VAS), and quality of life (EORTC QLQ-H&N35) will be available for sharing in a de-identified form after removal of personal identifiers. When: De-identified data will be available to researchers starting 6 months after the publication of the results and will remain accessible for 5 years after publication To whom: De-identified data will be available to researchers affiliated with universities or recognized research institutions, upon request and after approval by the ethics committee. Conditions: Data will be provided solely for research and scientific purposes in accordance with the objectives stated in the request; commercial use is not permitted. Analyses must align with the research plan submitted in the request; changing the primary objectives is not allowed. Data will be de-identified, and the applicant is required to maintain confidentiality and must not attempt to re-identify participants. Use of the data is subject to approval by the ethics committee and the principal investigator. In any reports or publications, data must be presented anonymously, preserving participant identity. Upon completion of analyses, the applicant is required to provide the final results or research report to the principal investigator upon request Where to obtain: Researchers wishing to access de-identified data must submit a formal request to the principal investigator. The request should include the intended use of the data, a proposed research plan, and a commitment to maintain data confidentiality. After review and approval by the ethics committee and the principal investigator, the data will be provided in secure, de-identified files. The review and data provision process typically takes 2 to 4 weeks. How to obtain: The applicant submits a formal request to the principal investigator, including the intended use of the data, a description of the proposed research plan, and a commitment to maintain data confidentiality. The principal investigator reviews the request and, if complete, forwards it to the ethics committee for approval. Upon approval by the ethics committee and the principal investigator, the de-identified data will be provided to the applicant in secure files. The entire process, from submission of the request to receiving the data, typically takes 2 to 4 weeks Comments:
public Seyde Sedighe Yousefi
Persian Medicine Faculty, Khazar Blvd, Sari
Sari Iran (Islamic Republic of) 4846895475 009833243117 dr_ssyosefi@yahoo.com Mazandaran University of Medical Sciences scientific Seyde Sedighe Yousefi
Persian Medicine Faculty, Khazar Blvd, Sari
Sari Iran (Islamic Republic of) 4846895475 009833243117 dr_ssyosefi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) above 18years old Patients with head and neck cancer candidates for radiotherapy Life expectancy of more than one year as estimated by the physician or medical team Physical and mental ability to cooperate in completing the questionnaire with a Karnofsky performance status > 50 Willingness to participate in the study Presence of at least two subsites of the oral mucosa within the radiotherapy field No known allergy to black mulberry or honey 18 years no limit Both Previous radiotherapy and history of chemotherapy within the last six months in the oral cavity and oropharynx region Presence of active oral infection or ulcer before initiation of radiotherapy Pregnancy Treatment - Drugs Treatment - Drugs Intervention group: Patients with head and neck cancer who are candidates for radiotherapy and meet the inclusion criteria will receive the mulberry and honey preparation. The standardized mulberry extract and standardized honey (with necessary approvals such as microbial testing) will be obtained from a reputable company approved by the Food and Drug Administration and will be produced in the form of an oral syrup (manufactured by Giah Kala Company). The dosage will be 5 mL of mulberry-honey syrup per administration, which should be kept in the mouth for 15 seconds and then swallowed. Control group: Patients with head and neck cancer who are candidates for radiotherapy and meet the inclusion criteria will receive benzydamine hydrochloride mouthwash. The prescribed regimen consists of three daily doses during radiotherapy, with 15 mL per dose, to be kept in the mouth for 30 seconds and then expelled. Oral Mucositis Severity. Timepoint: Assessment of oral mucositis severity every week from the start of intervention until two weeks after its completion. Method of measurement: Examination by a radio-oncology specialist based on the World Health Organization (WHO) oral mucositis scale. Oral pain. Timepoint: Daily until two weeks after the completion of the intervention. Method of measurement: Visual Analogue Scale. Quality of Life. Timepoint: Basis of intervention, third week of intervention, end of intervention, and two weeks after completion of intervention. Method of measurement: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Head & Neck 35. Mazandaran University of Medical Sciences Approved 2025-09-23 Research Ethics Committees of Mazandaran University of Medical Sciences Khazar Blvd, Faculty of Persian Medicine Sari Mazandaran Iran (Islamic Republic of)