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IRCT20220213054015N1 IRCT 2022-04-12 Karaj University of Medical Sciences Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial 2022-05-20 anticipated 70 Complete https://irct.ir/trial/61987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The patients will be randomly classified in two classes of melatonin and placebo using block randomization method (block of size 6), to randomize the experiment. The randomization sequence using a computer-based randomized list will be determined by a person not involved in patient registry, then the mouthwash bottles will be numbered according to the randomized list and by a person who was not involved in patient registry and examination of oral mucositis; anyone involved in patient registry and examination of oral mucositis will not be informed about the numbers related to drug or placebo during the study, Blinding description: This study is double blinded clinical trial, which means the patient and the researcher who provide the drug or placebo to the patients and evaluate the patients, are not aware whether the mouthwash is a drug or placebo.for this purpose, after making melatonin mouthwash and placebo which will both be exactly the same in appearance, these mouthwashes are poured into totally the same bottles by a researcher who is not involved in patient recruitment and examination of oral mucositis; then they are numbered in blocks of 6 size on a list of random computer numbers. it is worth noting that this list and that each number belongs to drug or placebo, is only available to the senior researcher (supervisor) who is not involved in the patient recruitment and examination of oral mucositis.Then, these completely similar bottles, on which only one number is installed, are given to the student (person responsible for patient recruitment) so that the student can provide the bottles to the patients in the order of the number of patients who entering the study. 3 chemotherapy-induced oral mucositis. Intervention 1: Intervention group:Patients will gargle 4 ml of melatonin mouthwash made in Alborz School of Pharmacy, three times a day (a measuring cup with defined volume will be provided to facilitate the use). The patients will be asked to keep the mouth wash in their mouth for a minute or as long as possible, before spitting out. The patients will be asked to avoid eating for the next 30 min after using the mouthwash. The mouthwash will be will be utilized from the first day of chemotherapy and will continue for the next 6 weeks. The purpose and advantages of this survey will be thoroughly explained to the patients to ensure the consistent use of mouthwash through the survey; patients will also be inquired to join the survey in case of possible consistent accompaniment and complete consent. The practice of mouthwash by the patients will regularly be monitored via telephone calls or social media. It should be noted that some errors might inevitably emerge during the survey. Intervention 2: Control group:Patients will gargle 4 ml of placebo mouthwash made in Alborz School of Pharmacy (without melatonin active ingredient in mouthwash formulation) three times a day (a measuring cup with defined volume will be provided to facilitate the use). The patients will be asked to keep the mouth wash in their mouth for a minute or as long as possible, before spitting out. The patients will be asked to avoid eating for the next 30 min after using the mouthwash. The mouthwash will be will be utilized from the first day of chemotherapy and will continue for the next 6 weeks. The purpose and advantages of this survey will be thoroughly explained to the patients to ensure the consistent use of mouthwash through the survey; patients will also be inquired to join the survey in case of possible consistent accompaniment and complete consent. The practice of mouthwash by the patients will regularly be monitored via telephone calls or social media. It should be noted that some errors might inevitably emerge during the survey. Yes - There is a plan to make this available What will be shared: All collected data. When: After the end of the study and its publication. To whom: Researchers. Conditions: Use for review studies. Where to obtain: Corresponding author email. How to obtain: Sending email. Comments:
public Elliyeh Ghadrdan
School of Pharmacy,Next to Bahonar Hospital, Vali-ye-Asr St.,Shura Blvd., Azimieh, Karaj,Alborz Provice
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 EL.ghardan@gmail.com Karaj University of Medical Sciences scientific Elliyeh Ghadrdan
School of Pharmacy,Next to Bahonar Hospital, Vali-ye-Asr St.,Shura Blvd., Azimieh, Karaj,Alborz Provice
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 EL.ghardan@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Age 18 and above. A patient with malignant solid tumor and candidate for chemotherapy (receiving medications with potential of almost similar mucositis: Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Gemcitabine, Dacarbazine, and Cisplatin). Karnofsky status ≥ ۶۰%. Oral and written satisfaction (consent) of patients to participate in survey. 18 years no limit Both Inability in using the mouthwash. Smoking. Increasing hypersensitivity to melatonin or any other components used in formulation. History of head and neck radiotherapy. Having any lesions inside the mouth. Prevention Prevention Intervention group:Patients will gargle 4 ml of melatonin mouthwash made in Alborz School of Pharmacy, three times a day (a measuring cup with defined volume will be provided to facilitate the use). The patients will be asked to keep the mouth wash in their mouth for a minute or as long as possible, before spitting out. The patients will be asked to avoid eating for the next 30 min after using the mouthwash. The mouthwash will be will be utilized from the first day of chemotherapy and will continue for the next 6 weeks. The purpose and advantages of this survey will be thoroughly explained to the patients to ensure the consistent use of mouthwash through the survey; patients will also be inquired to join the survey in case of possible consistent accompaniment and complete consent. The practice of mouthwash by the patients will regularly be monitored via telephone calls or social media. It should be noted that some errors might inevitably emerge during the survey. Control group:Patients will gargle 4 ml of placebo mouthwash made in Alborz School of Pharmacy (without melatonin active ingredient in mouthwash formulation) three times a day (a measuring cup with defined volume will be provided to facilitate the use). The patients will be asked to keep the mouth wash in their mouth for a minute or as long as possible, before spitting out. The patients will be asked to avoid eating for the next 30 min after using the mouthwash. The mouthwash will be will be utilized from the first day of chemotherapy and will continue for the next 6 weeks. The purpose and advantages of this survey will be thoroughly explained to the patients to ensure the consistent use of mouthwash through the survey; patients will also be inquired to join the survey in case of possible consistent accompaniment and complete consent. The practice of mouthwash by the patients will regularly be monitored via telephone calls or social media. It should be noted that some errors might inevitably emerge during the survey. Intensity of mucositis. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: World Health Organization Toxicity Scale. Intensity of pain. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: Visual analog scale. Quality of Life. Timepoint: At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash. Method of measurement: EORTC Quality of Life Questionnaire QLQ-C30. Karaj University of Medical Sciences Approved 2022-02-01 Ethics committee of Alborz University of Medical Sciences Safareyan St., Golshahr Ave. Karaj Alborz Iran (Islamic Republic of)