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 on the treatment of oral mucositis and oral pain reduction in patients with upper gastrointestinal tract tumors

Randomized, double-blinded, placebo-controlled, phase 2 trial on 98 patients. The permuted block randomization model with block size 4 will be conducted.

This study is a randomized double-blinded placebo-controlled clinical trial (the researcher, patient, and physician are blind). In this study, 98 patients with gastric or esophageal cancer referred to Shahid Rajaei Hospital will be recruited. Included patients are those who have developed grade 1 or 2 oral mucositis (according to WHO classification) after receiving a fluorouracil (5-FU) chemotherapy regimen.

Age of 18 years or above, Not anticoagulated or have coagulation disorders, 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

In this study, the effect of 20 mg/day oral melatonin in the treatment of oral mucositis will be evaluate. The intevention group will receive the standard treatment for oral mucositis plus 20 mg/day melatonin tablet. The control group will receive the standard treatment for oral mucositis plus placebo tablet.

Determination of the effect of oral melatonin on reducing the severity of mucositis and oral pain caused by chemotherapy for upper gastrointestinal tumors; Determination of side effects of melatonin compared with placebo; Determination of the effect of melatonin on patients' quality of life

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.

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.

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