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IRCT20220426054666N1 IRCT 2022-06-01 Karaj University of Medical Sciences The evaluation of the effect of oral melatonin in the treatment of oral mucositis and oral pain reduction in patients with upper gastrointestinal tract tumors The evaluation of the effect of oral melatonin in the treatment of oral mucositis and oral pain reduction in patients with upper gastrointestinal tract tumors 2022-08-21 anticipated 98 Complete https://irct.ir/trial/63207 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are placed in 4-person blocks using permuted block randomization method. In block randomization, blocks with the same or different sizes of individuals are first identified. Then, within each block, the assignment of individuals to each of the treatment groups is randomly determined. The number of blocks and people inside each block is determined according to the sample size of the whole study. Randomization software will be used to obtain individual sequences for blocks and random assignments, Blinding description: The researcher, patient and physician are blind to this study.In this study, the patient will be kept unaware of the group therapy with the help of a placebo. Also, the person who evaluates and treats the patients will be kept informed of the type of treatment. In this study, only one person (supervisor) will be aware of the allocation of people to treatment groups and randomization codes, and other people implementing the project or colleagues, as well as patients of the type of treatment and groups are kept unaware and drugs and interventions to The coded form will be provided and will be decoded only at the end of the code study (eg drug / group A and B). Therefore, the drugs as well as the placebo will be provided in the same form and without a name and only with a code for the treating physician and patients. 2 oral mucositis and oral pain in patients with upper gastrointestinal tract tumors. Intervention 1: Intervention group: Standard mucositis treatment plus melatonin tablets 20 mg/daily. Treatment will be continued until complete relief of symptoms (up to 2 weeks). Intervention 2: Control group: Standard mucositis treatment plus placebo tablets. Treatment will be continued until complete relief of symptoms (up to 2 weeks). Yes - There is a plan to make this available What will be shared: After deleting personal information ,the Spss file would be shared. When: From 1402 onward To whom: After authentication of researchers, they are permitted to access to data. Conditions: The only acceptable analyze are of researchers. Where to obtain: To take data/document refer to the responsible author of the article. How to obtain: Provided applicants being authenticated, they could access to data after utmost one month. Comments:
public Behin Marzban
Faculty of Pharmacy building-next to Bahonar Hospital-Valiasr St.-Shura Boulevard
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 pharmacy@abzums.ac.ir Karaj University of Medical Sciences scientific Mehdi Mohammadi
Faculty of Pharmacy building-next to Bahonar Hospital-Valiasr St.-Shura Boulevard
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 pharmacy@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Not anticoagulated No history of seizure No history of dementia No history of depression No history of diabetes Signing the informed consent form Patients with gastric or esophageal cancer that is under treatment with a f-FU-containing regimen and have developed grade 1 or 2 oral mucositis according to the WHO classification 18 years no limit Both Treatment - Drugs Placebo Intervention group: Standard mucositis treatment plus melatonin tablets 20 mg/daily. Treatment will be continued until complete relief of symptoms (up to 2 weeks). Control group: Standard mucositis treatment plus placebo tablets. Treatment will be continued until complete relief of symptoms (up to 2 weeks). Mucositis severity according to WHO classification and severity of patient oral pain according to common terminology criteria for adverse events (CTCAE) version 5.0 and Visual Analog Scale. Timepoint: Daily. Method of measurement: WHO scale for oral mucositis ,common terminology criteria for adverse events (CTCAE) version 5.0 ,Visual Analog Scale. Quality of life. Timepoint: daily. Method of measurement: European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC). Karaj University of Medical Sciences Approved 2022-04-16 Ethics committee of Alborz University of Medical Sciences Office of the Ethics Committee-2th floor-Deputy of Research and Technology-Safarian street-Golshahr Ave Karaj Alborz Iran (Islamic Republic of)