Dodd, M.J., Miaskowski, C., Greenspan, D., MacPhail, L., Shih, A., Shiba, G., … Paul, S.M. (2003). Radiation-induced mucositis: A randomized clinical trial of micronized sucralfate versus salt and soda mouthwashes. Cancer Investigation, 21, 21–33.

Patients with head and neck cancer receiving radiation therapy (RT) were instructed to use the PRO_SELF Mouth Aware (PSMA) Program, an oral hygiene protocol, throughout RT. Those who developed RT-induced oral mucositis (OM) were randomized to either 1 gm carafate or normal saline (NS) mouthwash. Patients were instructed to rinse with the mouthwash four times per day. Nurses who were trained in the intervention, PSMA, and oral assessment phoned the patients twice weekly until one month after RT. One month after RT completion, oral assessment was done.

The study reported on 30 adult patients with head and neck cancer receiving RT with or without chemotherapy. The mean age of the sample was 55.2 years.

This was a randomized, double-blind, clinical trial.

The MacDibbs Mouth Assessment was used to measure the severity of OM. Patients also recorded pain when swallowing. Healing, weight loss, tube feeds, breaks in RT, hospital admissions, and Karnofsky Performance Status Scale scores were recorded. The investigators used t-tests and chi-square analysis.

No significant differences were found in the two groups in terms of average worst severity rating (p = 0.85), severe pain (p = 0.54), MacDibbs scores at the end of RT (p = 0.61), average pain at the end of RT (p = 0.51), MacDibbs scores at the follow-up visit (p = 0.24), pain at the follow-up visit (p = 0.41), or days to heal (p = 0.19).

No significant differences were found for any of the other variables as well (e.g., weight loss, tube feeds, breaks in RT).

• The study sample was small.
• The study lacks statistical power.
• Some patients had oral lesions prior to the study.
• Adherence to the mouthwash protocol was modest.