Preparation and evaluation of the effect of hydrogel containing Saffron petal extract in prevention and reduction of severity of radiotherapy-induced acute dermatitis in breast cancer patients

Preparation and determination of the effect of hydrogel containing Saffron petal extract on the management of radiotherapy-induced mucositis

A double-blind, randomized, placebo-controlled, Phase 2-3 clinical trial study will be performed on 80 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 the clinics of Babol and Mashhad University of Medical Sciences. Patients are randomly assigned medication and placebo after obtaining informed consent. Patients will use the hydrogel twice a day based on the fingertip unit for six weeks and will be evaluated weekly by an oncologist.

Inclusion criteria: Female patients with diagnosed breast cancer, age 18 years and older, no skin tumour tissue, no concomitant chemotherapy, no previous chest radiotherapy, minimum 50 Gy radiation during treatment, BMI 20-30, Breast-conserving surgery Exclusion criteria: patients with underlying diseases, hypersensitivity to Portulaca oleracea, patients with metastatic carcinoma to the breast, Inability of the patient to implement the treatment protocol

Placebo group: Placebo hydrogel containing glycerin and green-red mixed dye made by Mashhad University of Medical Sciences, Intervention group: hydrogel containing 8% Saffron petal extract and glycerin content made by Mashhad University of Medical Sciences

Incidence and severity of chemotherapy-induced mucositis

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 the experiment: Six quadruple modes including: 1- AABB, 2- ABAB, 3-BBAA, 4-BABA, 5-BAAB and 6- ABBA Possible scenarios for two groups of 40 equal to 10 = 80/4 Randomly write 20 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 80, 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 a 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.