Abstract
BACKGROUND: Considering the prevalence of cetuximab-induced rashes in colorectal cancer patients and its impact on patient's quality of life and treatment, this study aimed at investigating the effect of topical vitamin K1 on the treatment of skin rashes in metastatic colorectal cancer patients treated with cetuximab. MATERIALS AND METHODS: This randomized, controlled, triple-blind, clinical trial was conducted on 49 metastatic colorectal cancer patients who were candidates for cetuximab treatment and referred to Omid Hospital in Isfahan during 2021-2022. Vitamin K1 cream with a concentration of 0.1% in the intervention group (n = 25) and placebo cream in the control group (n = 24) were prescribed twice a day (in the morning and before bedtime) for eight weeks. The rash grade was recorded based on common terminology criteria for adverse events-4 (CTCAE-4) criteria before the intervention and in the fourth and eighth weeks during the intervention. RESULTS: During the intervention, skin rash grades in the fourth and eighth weeks with the means of 1.00 ± 0.64 and 0.84 ± 0.55, respectively, were significantly lower in the intervention group, as compared with the control group with the means of 1.42 ± 0.65 and 1.25 ± 0.68, respectively (P value < 0.05). Moreover, the severity of skin rashes decreased significantly in the intervention group over time during eight weeks (P value < 0.05); however, its decrease was not significant in the control group (P value > 0.05). CONCLUSION: Topical vitamin K1 cream had a significant effect on reducing the severity of cetuximab-induced skin rashes over eight weeks of treatment.