oral mucositis. Oral mucositis (ulcerative) due to antineoplastic therapy
Conditions
Interventions
Intervention 1: Intervention group: receiving Bene oleoresin 1% mouthwash to be used twice daily for a week. Intervention 2: Control group: receiving placebo (absence of Bene oleoresin) to be applied
Sponsors
Islamic Azad University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age 18 to 75 years isn't first course chemotherapy Receipt of at least two cytotoxic drugs; a treatment tment regimen containing 5-fluorouracil (5fu); history of mucositis, dryness, or any oral complications in the previous courses of chemotherapy; absence of oral mucositis at the beginning of the study; performance status grade of less than or equal to two according to the Eastern Cooperative Oncology Group (ECOG) scale
Exclusion criteria
Exclusion criteria: Simultaneous radiotherapy in head and neck; sensitivity to the Pistacia atlantica; pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of the oral mucositis according to the World Health Organization grading system. Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: The World Health Organization Grading System.;Soreness or pain in the mouth. Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10.;Trouble with talking. Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10.;Trouble with eating solid foods (such as bread). Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10.;Trouble with eating soft foods (such as yogurt and baked potatoes). Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10.;Difficulty in swallowing due to the sore throat. Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10.;Taste changes. Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10.;Bleeding or sore gums. Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feeling of dryness in the mouth. Timepoint: Baseline and 3, 7, 14, 21 days after the intervention. Method of measurement: Patient-reported outcomes based on scoring 0 to 10. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAtefe Fathi
Islamic Azad University
Outcome results
None listed