oral mucositis and oral pain in patients with upper gastrointestinal tract tumors.
Conditions
Interventions
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: Con
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: daily. Method of measurement: European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehin Marzban
Karaj University of Medical Sciences
Outcome results
None listed