The effect of Malva sylvestris mouthwash on chemotherapy-induced stomatitis and associated pain in patients with cancer: a triple-blind randomized clinical trial.

BACKGROUND AND OBJECTIVES: Stomatitis is among the most debilitating complications of cancer treatment, particularly chemotherapy. The use of medicinal plants has been suggested as a potential therapeutic approach to mitigate this condition. This study aimed to evaluate the effect of Malva sylvestris (mallow) mouthwash on chemotherapy-induced stomatitis in cancer patients. MATERIALS AND METHODS: This triple-blind randomized clinical trial was conducted in 2024 on 70 cancer patients with chemotherapy-induced stomatitis who attended medical centers in an urban area of Iran. Participants were randomly allocated to two groups using the minimization method. The intervention group received 15 ml of Malva sylvestris mouthwash three times daily for 14 days, while the control group received standard chlorhexidine mouthwash. The severity of stomatitis and associated pain were assessed at baseline and on days 3, 7, and 14 using the World Health Organization (WHO) Mucositis Scale and the Visual Analog Scale (VAS) for pain, respectively. Data were analyzed using SPSS version 22. RESULTS: Before the intervention, no statistically significant differences were observed in mean stomatitis or pain scores between the two groups. By day 7, the intervention group demonstrated significantly lower mean scores for both stomatitis and pain compared with the control group (P < 0.001). Moreover, the reduction in stomatitis severity over time was greater in the intervention group than in the control group (P < 0.05). On day 14, although the intervention group maintained lower mean stomatitis scores, the difference between the two groups was not statistically significant (P = 0.08). CONCLUSION: The findings suggest that Malva sylvestris mouthwash has a beneficial effect in reducing the severity of stomatitis and associated pain in patients undergoing chemotherapy. Therefore, its use may be recommended as a supportive intervention for patients, caregivers, and healthcare professionals involved in cancer care. TRIAL REGISTRATION: Trial registration number: IRCT20150713023190N15. Date of registration: 2024/07/20.