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IRCT20191023045223N1 IRCT 2020-07-29 Islamic Azad University Bene mouthwash for prevention of chemotherapy-induced oral mucositis Evaluation of Bene (Pistacia atlantica) oleoresin mouthwash for prevention of chemotherapy-induced oral mucositis 2019-12-22 anticipated 50 Complete https://irct.ir/trial/49772 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The blockchain randomization is employed and random number table is used as the randomization tool, Blinding description: A person not involved in the study will code the mouthwashes and the coded mouthwashes will be given to the patients. The participants, the researcher, the data analyst, and the healthcare providers involving the physician and the nurses will not be aware of the codes. 2 oral mucositis. 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 twice daily for a week. Yes - There is a plan to make this available What will be shared: Bene mouthwash for prevention of the chemotherapy-induced oral mucositis When: 6 months after publication To whom: People working in academic institutions Conditions: Full description of the intended analyses and the applications Where to obtain: Dr. Atefeh Fathi, E-mail: a.fathi2696@gmail.com How to obtain: If the request was accepted, the data would be sent to the applicant as soon as possible Comments:
public Atefe Fathi
Yakhchal st., Gholhak st., Dr. Shariati st.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 a.fathi2696@gmail.com Islamic Azad University scientific Dr. Mehdi Rajabi
Yakhchal st., Gholhak st., Dr. Shariati st.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 mehdirj@aol.co.uk Islamic Azad University Iran (Islamic Republic of) 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 18 years 75 years Both Simultaneous radiotherapy in head and neck; sensitivity to the Pistacia atlantica; pregnancy and lactation K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy Prevention Prevention Intervention group: receiving Bene oleoresin 1% mouthwash to be used twice daily for a week Control group: receiving placebo (absence of Bene oleoresin) to be applied twice daily for a week 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. 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. Islamic Azad University Approved 2019-09-02 Ethis committee of Islamic Azad University of Tehran Medical Sciences Yakhchal st., Gholhak st., Dr. Shariati st. tehran Tehran Iran (Islamic Republic of)