Condition 1: Nausea and Vomiting. Condition 2: brain tumor. Nausea and vomiting Malignant neoplasm of brain
Conditions
Interventions
Intervention 1: Control group: Patients in the control group will receive 4 mg of Ondansetron orally three times a day (every 8 hours). The medication will be started on the first day of radiotherapy
Sponsors
Yazd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years Patient eligible for brain radiotherapy (primary or secondary) Obtaining informed consent from the patient or their legal guardian A patient who was about to initiate the radiotherapy process and was scheduled to receive the first treatment fraction. Patients who were scheduled to receive only a single course (phase) of radiotherapy
Exclusion criteria
Exclusion criteria: Vomiting or the need for any rescue antiemetic therapy at baseline and prior to initiation of tumor treatment Pregnancy or breastfeeding Presence of hepatic and renal failure Patient’s noncompliance with proper and regular use Patients who develop intolerable or serious adverse effects due to medication use Occurrence of an allergic reaction to the drug Patient’s unwillingness to continue the study for any reason Discontinuation of radiotherapy for any reason by the patient or the physician during the study period Incomplete recording of the required treatment information by the patient Use of medications by the patient that are contraindicated for concurrent administration with mirtazapine due to drug interactions, such as MAO inhibitors, linezolid, tranylcypromine, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with “complete control”; defined as no vomiting, no need for rescue medication, and no clinically significant nausea (nausea grade 0 or 1 based on the Common Terminology Criteria for Adverse Events Version 5.0). Timepoint: ??? ?????? (?? ?? ??? ???? ?? ?? ???? ??????????). Method of measurement: Data on nausea, vomiting, and rescue medication use will be extracted from the patients’ daily questionnaires, and nausea severity will be graded according to the Common Terminology Criteria for Adverse Events Version 5.0. Based on these data, the “complete control” status will then be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients with “complete control” (CC) in the acute and overall phases; defined similarly to the primary outcome based on the Common Terminology Criteria for Adverse Events Version 5.0. Timepoint: Acute phase (0 to 24 hours), overall phase (0 to 168 hours). Method of measurement: The data from the patients’ daily questionnaires will be analyzed and graded according to the Common Terminology Criteria for Adverse Events Version 5.0 to determine the “complete control” status.;The percentage of patients with “total control” (TC); defined as no nausea (grade 0 based on the Common Terminology Criteria for Adverse Events Version 5.0), no vomiting, and no need for rescue medication. Timepoint: Acute phase (0 to 24 hours), delayed phase (24 to 168 hours), and overall phase (0 to 168 hours). Method of measurement: Based on the data recorded in the patients’ daily questionnaires and the grading of nausea using the Common Terminology Criteria for Adverse Events Version 5.0.;Severity, frequency, and degree of interference with daily activities caused by adverse effects related to Mirtazapine (e.g., drowsiness, increased appetite, dry mouth, dizziness, and constipation). Timepoint: After completing the 7-day course of Mirtazapine administration. Method of measurement: Using the standardized Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (PRO-CTCAE v1.0), which assesses severity, frequency, and functional interference based on the patient’s self-report. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactParsa Yabande Jahromi
Yazd University of Medical Sciences
Outcome results
None listed