Evaluation of the effectiveness of mucoadhesive mouthwash containing saffron petal extract on prevention and improvement of clinical symptoms of radiotherapy-induced oral mucositis

Determining the effectiveness of saffron mouthwash on the management of radiotherapy-induced mucositis

A double-blind, randomized, placebo-controlled clinical trial study will be performed on 40 individuals divided into two groups. Randomization will be done using the blocking method and random selection with the help of the Randomaize.com randomization site.

The study will be performed in patients referred to clinics of Mashhad University of Medical Sciences. Patients are randomly assigned medication and placebo after obtaining informed consent. Patients will use 10 ml of mouthwash in the morning and night and will be evaluated weekly by an oncologist.

-Inclusion criteria: Patients treated for head and neck cancer with chemoradiotherapy; Age between 18 and 70 years; Absence of serious dental problems; Absence of impacted teeth; No presence of cusps or sharp filling; Total radiation between 50 to 70 Gy during treatment; Exposure of at least half of the oral cavity to radiation; Patients should receive one of the drugs cisplatin or 5-fluorouracil in their chemotherapy diet. -Exclusion criteria: Severe infections that require antibiotics; Patients who have been allergic to any of the herbal extracts or previous radiotherapy; The inability of the patient to implement the treatment protocol; Renal failure (eGFR <50 ml / min); Liver failure (serum level 2 to 3 times higher than normal) .

Placebo group: Acetaminophen 500 mg + placebo mouthwash containing distilled water and glycerin made by Mashhad University of Medical Sciences Intervention group: Acetaminophen 500 mg + mouthwash containing 1% extract of saffron petals containing distilled water and glycerin made by Mashhad University of Medical Sciences

Change in mucositis score based on World Health Organization scores

Due to mouthwash preparation and its stability problems, the patient collection has not yet started. However, the researchers predict that patient recruitment will begin on 21/11/2024.

Randomization takes place in three stages: 1- Creating a random sequence: in this stage of block randomization: quadruple blocks; Possible scenarios for two groups of experiment: Six quadruple modes including: 1- AABB, 2- ABAB, 3-BBAA, 4-BABA, 5-BAAB and 6- ABBA Possible scenarios for two groups of 20 equal to 10 = 4/40 Randomly write 10 blocks (using a table of random numbers) Write the final equivalent block Coding and allocating patients to receive medicine or placebo after opening the envelopes from number 1 to number 40, respectively. 2- Hide random allocation, which is done in the form of coded boxes with the random sequence with the help of random numbers table. In this method, a number of boxes of the same shape and size are numbered in random order and contain a medicine or placebo that have exactly the same regarding the appearance. 3- Execution of random allocation process: -The person who creates the random sequence: statistics consultant - The person who evaluates and registers the participants in terms of inclusion and exclusion criteria: Student of the project - The person who assigns the participants to the groups: Oncologist

Due to the use of placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell.