Oral mucositis is one of the major toxicities caused by
radiation therapy (RT) treatments to the head and neck. The clinical efficacy of
sucralfate (
Carafate R) mouthwash for
head and neck cancer patients (HNC) is not consistent across studies. In this study, it was hypothesized that if the particles in the original
sucralfate suspension were micronized (i.e., < or = 25 microns) then the coating action of the mouthwash in the oral cavity would be enhanced. The purpose of this pilot study was to compare the efficacy of micronized
sucralfate (
Carafate R) mouthwash and
salt & soda mouthwash in terms of the severity of the
mucositis, the severity of
mucositis-related
pain, and the time required to heal RT-induced
mucositis in patients with HNC. Severe
mucositis and related
pain can interfere with the ingestion of food and fluids, so patients'
body weights were measured as well. All patients in this randomized clinical trial carried out a systematic
oral hygiene protocol called the PRO-SELF: Mouth Aware (PSMA) Program. Patients who developed RT-induced
mucositis anytime during their course of RT were randomized to one of the two
mouthwashes and followed to the completion of RT and at one month following RT. Two referral sites were used for the study. Repeated measures occurred with the following instruments/variables: MacDibbs Mouth Assessment and weight. Demographic, disease, and
cancer treatment information was also obtained. Thirty patients successfully completed the study. The typical participant was male (70%), married/partnered (70%), White (63%), not working or retired (73%), and had an average of 14.5 years of education (SD = 3.7). T-tests and Chi-square analyses with an alpha set at 0.05 were used to compare differences between the two
mouthwashes. No significant differences were found in the number of days to onset of
mucositis (i.e., 16 +/- 8.4 days). When patients had their worst MacDibbs score, (i.e., the most severe
mucositis), there were no significant differences between the
mouthwashes as to MacDibbs score, the RT dose received, or ratings of
pain (upon swallowing). Similarly, at the end of RT, no significant differences were found between
mouthwashes as to MacDibbs scores or ratings of
pain (upon swallowing). At the one-month follow-up assessment no significant differences were found between the
mouthwashes in MacDibbs scores or
pain ratings (upon swallowing). The analysis of the efficacy of the two
mouthwashes revealed no significant differences in the time to heal (in days) from the RT-induced
mucositis. The findings from this trial provide important clinical information regarding cost analysis of RT
mucositis management. Given that there is no significant difference in efficacy between micronized
sucralfate and
salt & soda, use of the less costly
salt & soda is prudent and cost-effective.