Oral mucositis (OM) is a debilitating side effect of cancer therapy that can have a significant negative impact on health, quality of life, and treatment outcomes. Occurrence leads to dose reductions, delay in cancer therapy, discontinuation of therapy, and hospitalizations. Almost all patients with head and neck cancer who undergo radiation/chemoradiation develop some grade of oral toxicity and pain.1 An estimated 40% or more of cancer patients undergoing chemotherapy will experience OM, and incidence among patients who receive high doses of chemotherapy during bone marrow transplantation is 76%.2-4 Oral mucositis poses a significant challenge for the patient and the clinician, as well as increases the overall cost burden to institutions, insurance carriers, and patients.
Oral mucositis is generally associated with radiation therapy to the head and neck and cytotoxic agents such as fluorouracil (5-FU), bleomycin, cytarabine (Cytosar-U, Depocyt, generics), doxorubicin (Doxil, generics), methotrexate (Trexall, generics), and paclitaxel (Abraxane, Taxol, generics).2,5 The emergence of targeted agents was thought to hold a promise of lowering overall oral mucositis incidence; however, a high incidence of oral mucositis is reported in patients receiving mTOR inhibitors and other targeted agents.6 The etiology of oral mucositis is different with these new agents compared with OM caused by radiation and standard cytotoxic agents.7 Numerous pharmacologic approaches for prevention and treatment have been investigated; however, given the diversity of mucositis etiology, a single pharmacologic approach is not likely to be successful when a broad spectrum of anticancer treatments could be the cause.
A common feature of oral mucositis from all causes is mucosal damage. One approach to slowing mucositis progression, no matter the etiology, is to provide a protective barrier over the mucosa. Although a number of oral rinses have been tried, they either lack evidence-based supportive data of benefit or are not recommended in the guidelines from the European Society of Medical Oncology (ESMO), the Multinational Association of Supportive Care in Cancer (MASCC), the American Society of Clinical Oncology (ASCO), the American Society of Radiation Oncology (ASTRO), or the Oncology Nursing Society (ONS).8 These products/solutions are mostly suboptimal treatments; however, many of them continue to be used because not many evidenced-based therapeutic options are available. Managing the adverse effects of OM is extremely frustrating for oncology nurses, resulting in a willingness to try anything that could potentially help patients.
At Rush University Medical Center, most of these products were also unsuccessful in alleviating OM in our patients. We decided to try MuGard, a new mucoadhesive polymer oral wound rinse from Access Pharmaceuticals Inc, shortly after it became available in the United States. An initial clinical study by Access Pharmaceuticals on the use of MuGard by patients with head and neck cancer undergoing chemoradiation indicated that the product significantly reduced the severity of oral mucositis, compared with historical controls, when its use began at the same time as cancer therapy. Interim results of a randomized, double-blind, placebo-controlled study, also in head and neck patients undergoing chemoradiation, demonstrated a meaningful treatment benefit, with several parameters reaching statistical significance.9 In parallel with that study, a clinical evaluation of MuGard for OM was conducted at Rush University Medical Center to investigate its clinical effect on pain severity, need for narcotics during treatment and posttreatment recovery, OM toxicity, and the patients’ ability to maintain their weight while undergoing radiation/chemoradiation for cancers in the head and neck region. This article summarizes the results of the Rush University clinical evaluation.
METHODS AND ANALYSIS
We prescribed MuGard to 128 patients who were commencing on radiation therapy for a primary head and neck cancer over an 18-month period (Table 1). Patients were instructed to gently swish and swallow 5 mL of MuGard four to six times a day starting on the first day of cancer treatment and continuing for 1 week or longer after their last treatment. The patient’s weight, pain assessment (on a scale of 0 to 10), oral assessment, and National Cancer Institute (NCI) OM toxicity were documented biweekly. In analyzing the data, we found that 102 of the patients adhered to the patient instructions. Therefore, for the purpose of further analysis, the data were divided into two cohorts: those who adhered to the instructions given for use and those who were nonadherent. Statistical analyses were conducted by grouping the data into 2×2 contingency tables and determining P values according to two-sided (two-tailed) Fisher’s exact test. An association between the cohorts (adherent and nonadherent) and an outcome parameter was considered to be significant with a P value of less than .05.
Table 1. Demographics of Rush study population
|Cancer type||Number of patients|
|Large cell lymphoma||1|
|Other head and neck||7|
|Other demographic data|
|Average age||59 y|
|Age range||14-85 y|
FINDINGS AND IMPLICATIONS
For the purpose of data analysis, patients who failed to adhere to the instructions for using the oral rinse (ie, they did not use the rinse or used it infrequently) were the control cohort. Eleven patients dropped out of the evaluation before completing at least 6 weeks of treatment. Data from these patients were included in the analysis.
The patients who adhered to the instructions for using the oral rinse had a mean OM grade of 1 to 2 on the NCI OM toxicity grading scale, maintained their weight, and reduced their need for narcotics. Of the 26 patients who did not use the oral rinse as instructed, 13 of them developed grade 3 OM. Our results indicate that MuGard is a powerful tool for reducing OM incidence, significant weight loss, and narcotic use in patients undergoing radiation therapy to the head and neck region. This evaluation correlates with the findings of a randomized, placebo-controlled study in which MuGard was found to be more effective than saline bicarbonate rinse for OM in 70 patients.9