BACKGROUND:Oral mucositis is a common complication of cancer therapy. Animal models suggest that curcumin may prevent oral mucositis. To date, no clinical studies have been reported. OBJECTIVE: The primary aim of this pilot study was to assess the tolerability of a curcumin mouthwash. The secondary aim was to describe oral mucositis in pediatric patients undergoingdoxorubicin-containing chemotherapy who were using the curcumin mouthwash. METHOD: The research team had originally designed a placebo-controlled study, but gastrointestinal adverse events (nausea and vomiting) affected the compliance of the first three participants who entered the study. An independent researcher found that all three had received the placebo. Believing it unethical to continue using the study's original design, the research team discontinued the control group, and the resulting study is comparable to a case series. SETTING: The research team performed the study at Hadassah University Medical Center in Jerusalem, Israel. PARTICIPANTS: Participants were seven pediatric and young-adult oncology patients. INTERVENTION: In addition to standard, preventive oral care (chlorhexidine 0.2% mouthwash for 30 s twice per day), participants also used 10 drops of Curcumall twice per day in a mouthwash during treatment with highdose chemotherapy. PRIMARY OUTCOME MEASURES: Oral mucositis was assessed on days 0, 7, 10, 14, and 21. The World Health Organization (WHO) scale, the Oral Mucositis Assessment Scale (OMAS), and a Visual Analog pain scale (VAS; patient reporting scale of 0-10) were used. Adverse events were tracked. RESULTS: No oral adverse events were documented. No systemic adverse events that possibly could be related to the use of the curcumin mouthwash were observed. In the four patients who fulfilled the compliance criteria, the WHO, OMAS and VAS scores were lower than the severity of oral mucositis previously reported in the literature. Four out of the five participants developed OM, but the values were low, reflecting a relatively mild case. CONCLUSION: In this study, the research team suggested that curcumin mouthwash was safe and well-tolerated. More research is warranted about the efficacy of topical curcumin in the prevention of oral mucositis.
RCT Entities:
BACKGROUND:Oral mucositis is a common complication of cancer therapy. Animal models suggest that curcumin may prevent oral mucositis. To date, no clinical studies have been reported. OBJECTIVE: The primary aim of this pilot study was to assess the tolerability of a curcumin mouthwash. The secondary aim was to describe oral mucositis in pediatric patients undergoing doxorubicin-containing chemotherapy who were using the curcumin mouthwash. METHOD: The research team had originally designed a placebo-controlled study, but gastrointestinal adverse events (nausea and vomiting) affected the compliance of the first three participants who entered the study. An independent researcher found that all three had received the placebo. Believing it unethical to continue using the study's original design, the research team discontinued the control group, and the resulting study is comparable to a case series. SETTING: The research team performed the study at Hadassah University Medical Center in Jerusalem, Israel. PARTICIPANTS: Participants were seven pediatric and young-adult oncology patients. INTERVENTION: In addition to standard, preventive oral care (chlorhexidine 0.2% mouthwash for 30 s twice per day), participants also used 10 drops of Curcumall twice per day in a mouthwash during treatment with highdose chemotherapy. PRIMARY OUTCOME MEASURES: Oral mucositis was assessed on days 0, 7, 10, 14, and 21. The World Health Organization (WHO) scale, the Oral Mucositis Assessment Scale (OMAS), and a Visual Analog pain scale (VAS; patient reporting scale of 0-10) were used. Adverse events were tracked. RESULTS: No oral adverse events were documented. No systemic adverse events that possibly could be related to the use of the curcumin mouthwash were observed. In the four patients who fulfilled the compliance criteria, the WHO, OMAS and VAS scores were lower than the severity of oral mucositis previously reported in the literature. Four out of the five participants developed OM, but the values were low, reflecting a relatively mild case. CONCLUSION: In this study, the research team suggested that curcumin mouthwash was safe and well-tolerated. More research is warranted about the efficacy of topical curcumin in the prevention of oral mucositis.
Authors: Aurigena Antunes de Araújo; Hugo Varela; Caroline Addison Carvalho Xavier de Medeiros; Gerly Anne de Castro Brito; Kênio Costa de Lima; Ligia Moreno de Moura; Raimundo Fernandes de Araújo Júnior Journal: PLoS One Date: 2015-02-17 Impact factor: 3.240