Investigating the effect of Malva sylvestris mouthwash on chemotherapy-induced stomatitis in cancer patients

Determining the effect of Malva sylvestris mouthwash on chemotherapy-induced stomatitis in cancer patients

A clinical trial with a control group, with parallel groups, double-blind, randomized, on 70 patients

The research population is cancer patients in Rafsanjan city. The samples are selected according to the available method and based on the selection criteria and by the random minimization method based on the severity of stomatitis and the amount of pain in two intervention and control groups. Patients in the intervention group received Khatami mouthwash and the control group received chlorhexidine mouthwash for fourteen days.

Full consciousness, consent to participate in the study, confirmation of cancer, chemotherapy without simultaneous radiation therapy, having stomatitis caused by first to third degree chemotherapy, at least one history of chemotherapy, age between 20 and 75 years, no history of sensitivity According to the malvaceae family, not having a mucosal lesion in the oral cavity before chemotherapy treatment, not being pregnant and not breastfeeding are the criteria for entering the study. Irregular use of mouthwash in terms of time and amount (forgetting 3 alternate days in a 14-day period completely), use of another mouthwash during the study, fever above 5.38, patient's decision to leave the study and unwillingness to use mouthwash and the outcome Any conditions that cause not to use mouthwash, such as worsening of the patient's condition, death, constitute the exclusion criteria.

Patients keep fifteen milliliters of mouthwash solution in their mouth for three minutes for fourteen days and spit it out. The intervention group uses marshmallow mouthwash. The control group receives normal chlorhexidine mouthwash solution.

Stomatitis; pain caused by stomatitis

The sample size was estimated to be 35 people in each group based on statistical formulas. The samples are selected according to the available method and based on the selection criteria and by the random minimization method based on the severity of stomatitis and the amount of pain in two intervention and control groups. In this method, classes are first formed based on the desired variables, then the first samples are randomly entered into the study and placed in each of the two groups. For the next samples, the sum of the indicators in two groups is taken into account, and the sample is assigned to the group that has a lower sum (table below). Class variable Intervention group control group Severity of stomatitis First degree stomatitis Second degree stomatitis Third degree stomatitis Stomatitis pain score 0-3 4-6 7-10

Drug and placebo are similar in terms of shape, type of packaging, color. For the purpose of blinding, the pharmacist is asked to identify the drug and the placebo as A and B so that the researcher does not know whether they are drugs or placebo, the patients are given only as drugs A and B, and the patient is also given It will not be known whether it is a drug or a placebo. This blinding will also exist for the analyzer, and after the analysis is finished, the pharmacist will be asked whether the mouthwashes A and B are drugs or placebo.