Ala, S., Saeedi, M., Janbabai, G., Ganji, R., Azhdari, E., & Shiva, A. (2016). Efficacy of sucralfate mouth wash in prevention of 5-fluorouracil induced oral mucositis: A prospective, randomized, double-blind, controlled trial. Nutrition and Cancer, 68, 456–463. 

To determine the efficacy of sucralfate mouthwash in the prevention of oral mucositis (OM) in patients receiving fluorouracil (5-FU) chemotherapy

Patients 18 years and older receiving chemotherapy containing 5-FU and calcium folinate were randomized into two groups through a computer-generated list of random numbers. One group received sucralfate suspension mouthwash and the other group received a placebo. Both groups received 10 ml of either sucralfate or placebo mouthwash every six hours for 10 days after the last dose of chemotherapy. Patients were instructed to rinse their mouth with the suspension for at least five minutes and spit it out 30 minutes after meals to ensure prolonged exposure of the mouthwash to the mucosal membranes.

• N = 51   
• AGE = Older than 18 years
• MALES: 15 (sucrafate group), 20 (placebo group); FEMALES: 10 (sucralfate group), 6 (placebo group)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Gastrointestinal cancer (e.g., esophageal, colon, rectal, gastric)

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Imam Khomeini Educational Hospital, Sari, Iran

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care, palliative care 

• Double-blind, randomized controlled study

• World Health Organization (WHO) grading system for mucositis
• Visual analog scale (VAS) to grade pain intensity

A statistically significant difference in the severity of mucositis was shown between the sucrafate group and placebo group on both day 5 and day 10 (p = 0.005, p < 0.001), respectively. The severity of mucositis in the sucrafate group on day 5 and 10 was grade 0. The majority of patients in the placebo group had a mucositis severity grade 2 on day 5 and day 10. A statistically significant reduction in pain intensity was shown in the sucrafate group versus the placebo group on both day 5 and day 10 (p = 0.004, p = 0.001), respectively.

Sucralfate mouthwash may be more effective than placebo in the prophylaxis of 5-FU–induced OM. A correlation between both the reduction of pain intensity and mucositis severity was shown with the use of the sucralfate mouthwash suspension, further confirming the role of sucralfate in the prophylaxis of OM in patients receiving 5-FU chemotherapy.

• Small sample (< 100)

Sucralfate mouthwash may be effective in reducing the severity and pain intensity of OM in patients receiving 5-FU.