Effects of nanomicelle curcumin capsules on prevention and treatment of oral mucosits in patients under chemotherapy with or without head and neck radiotherapy: a randomized clinical trial

BACKGROUND: One of the most prevalent complications of chemotherapy and radiotherapy is oral mucositis (OM) and manifests as erythema and ulceration. Curcumin is one of the components of turmeric and possesses anti-inflammatory and anti-oxidative features. Some of studies have proved the effectiveness of Curcumin in OM. This study aimed to investigate the effects of nanomicelle Curcumin on OM related chemotherapy and head and neck radiotherapy. METHODS: In this clinical trial study, 50 patients underwent chemotherapy with or without head and neck radiotherapy were divided into study and control group. The study group was received Curcumin nanomicelle capsules 80 mg twice a day and the control group took placebo two times a day for 7 weeks and the severity and pain of OM was measured. RESULTS: Oral mucositis severity in control group in the first (P = 0.010), fourth (P = 0.022) and seventh (P < 0.001) weeks were significantly more than the study group. Pain grade in study group was lower than control group only in the seventh week. (P = 0.001) Additionally, NRS incremental gradient in control group was more than study group. OM severity in patients who underwent only chemotherapy in the control group were significantly more than the study group in all weeks. In patients who were under chemotherapy and head and neck radiotherapy, OM in control group was significantly more intense than the study group only in the fourth and seventh weeks. CONCLUSIONS: Nabomicelle Curcumin capsules is effective on prevention and treatment of head and neck radiotherapy and especially chemotherapy induced OM. TRIAL REGISTRATION: Registered 12 February 2019 at Iranian Registry of Clinical Trials (IRCT). IRCT code: IRCT20100101002950N6. https://en.irct.ir/trial/36665. GUMS ethical code: IR.Gums.Rec.1397.296.