Background: Stomatitis as one of the serious side effects of chemotherapy is associated with multiple problems and worse of all failure of cancer treatment. This study aims to investigate the effect of hydroalchoholic extract of the Althaea root in the treatment of stomatitis pain related to chemotherapy. Methods: This triple-blind clinical trial was carried out on 50 cancer patients with chemotherapyinduced stomatitis and oral pain, who referred to the Oncology Centre of Shahid Beheshti Hospital, Kashan, Iran. The control group was treated with 15 mL of routine mouthwash solution four times a day for 14 days, whereas the experimental group was treated with half of routine mouthwash solution combined with Althaea root extract (50.50). The severity of stomatitis pain was evaluated using Visual Analog Scale at the baseline, and then 7 and 14 days after the study. The obtained data were analyzed using the Chi-square test, Fisher's exact test, Independent t test, and repeated measures ANOVA in SPSS-PC V. 19. Results: At the base line, the mean score of oral pain in the control group was 4.28(1.39), which reduced to 2.36(1.18) and 1.60(1.15) on the 7 th and 14 th day, respectively after the intervention. In the experimental group, the mean score of oral pain was 4.36(1.70) at the baseline which reduced to 2.72(1.67) on the 7 th day and 1.12(1.56) on the 14 th day (P=0.02, for the two groups, and in three different time points). The results showed that the reduction of the severity of stomatitis pain was statistically significant in the experimental group compared with the control group (P<0.05). Conclusion: Althaea root extract can be used as a suitable and safe mouthwash for relief of stomatitis oral pain in patients undergoing chemotherapy.

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