Nottage, M., McLachlan, S.A., Brittain, M.A., Oza, A., Hedley, D., Feld, R., … Moore, M.J. (2003). Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: A randomized, placebo-controlled trial. Supportive Care in Cancer, 11(1), 41–47.

To evaluate the effectiveness of sucralfate mouthwash in preventing 5-fluorouacil (5-FU) -induced oral mucositis (OM)

Patients were block randomized to receive sucralfate or an identical-appearing placebo. They were instructed to swish 10 ml of mouthwash for 2 minutes and then swallow it. The mouthwash was to be used four times per day starting on day 1 of radiation therapy (RT) and continuing until day 15.

Patients received throat swabs at the beginning of treatment to exclude infection. All patients used cryotherapy and the same salvage treatment (xylocaine topical, acetaminophen/codeine, then morphine sulfate if needed).

Patients were given 1 liter of study drug, and compliance was assessed by the volume left over after day 15. Research nurses contacted each patient by telephone after one week to assess compliance with the mouthwash and complete questionnaires.

• The study reported on 81 patients with colorectal cancer receiving 5-FU and leucovorin for one cycle; 42 patients were in the sucralfate group and 40 were in the placebo group.)
• The median age of patients was 61 years.

This was a randomized, double-blind, placebo-controlled trial.

Patients graded the severity of mucositis at the same time each day (in the evening) for 15 days using a 0–4 rating scale developed by the North Central Cancer Treatment Group. In addition, 1–6 analgesic diaries, the McGill Pain Questionnaire, and a 0–10 quality of life measurement tool were used on follow-up visits.

No significant differences were found between the two groups in terms of the following measures.

• Sum of daily mucositis score (p = 0.86)
• Daily pain score (p = 0.90)
• Eating difficulty (p = 1.00)
• QOL (p = 0.57)
• Duration of mucositis (p = 0.74)
• Number of analgesics (p = 0.19)

More women experienced mucositis than men.

The patient and medical assessments differed, and the authors stated that patient reporting is believed to be more sensitive.

The study did not conclude that sucralfate was an effective solution for the prevention of oral mucositis in this study population.

• The trial was closed early because the placebo expired.
• The trial did not meet patient accrual numbers.
• Medical staff underestimated mucositis incidence.
• The study lacked statistical power.
• No daily assessment was done.
• The placebo mouthwash was not described.