ROLE OF VITAMIN E AND VITAMIN A ON THE SEVERITY OF ORAL MUCOSITIS CAUSED BY CHEMOTHERAPY. A RANDOMIZED DOUBLE-BLIND CROSS-OVER CLINICAL TRIAL

Authors: Hossein GHOLAMI, Mohamad Amir MOHAMADIFARD, Freshteh OSMANI, Leili ALIZADEH

Abstract:

Introduction: Chemotherapy, widely used in cancer treatment, frequently leads to oral mucositis, a distressing and painful side effect. Despite numerous studies, there is currently no definitive approach to prevent and treat mucositis.  Aim: This study aims to explore the potential efficacy of vitamin E and vitamin A on preventing chemotherapy-induced oral mucositis through oral consumption. Materials and methods: The study was conducted as a randomized, double-blind cross-over clinical trial study design. 20 eligible participants underwent two cross-over phases based on specific criteria. In the first phase, they received orally vitamins E and A alongside chemotherapy, followed by a phase where they received a placebo. The severity of mucositis and patients’ pain response were assessed at the beginning of each phase and on days 7, 14, and 21 after treatment initiation. The collected data was analyzed using the SPSS software version 18, with a significance level set at less than 0.05. Results and discussion: Twenty participants, 14 (70%) females, with a mean age of 52.2 ± 14.37 years, successfully completed the study. Statistical analyses indicated no significant differences in mucositis severity between the control and intervention groups at study’s beginning and throughout the chemotherapy period (P > 0.05). Furthermore, no significant variations were observed in mucositis severity and patients’ pain response across different study days during the control and intervention phases (P > 0.05). Conclusions: The oral consumption of vitamins E and A showed no significant effect in reducing the severity of chemotherapy-induced oral mucositis or in alleviating patients’ pain response.

Keywords:
  • cross-over controlled trial
  • diet therapy
  • mucositis
  • oral
  • prevention and control