Relief of Painful Oral Mucositis
Oncologists at 26 sites enrolled 217 patients into this open-label, non-randomized observational study, called the Caphosol Oral Mucositis Follow-up Observational Registry Trial (COMFORT). Patients must have been undergoing chemotherapy and radiation and at high risk of developing OM. Thirty-one percent of the patients had head and neck cancer (HNC), 31 percent had breast cancer, 13 percent had colon cancer, eight percent had lung cancer, six percent had lymphoma and 11 percent had other tumor types. All patients in this study received CAPHOSOL, administered as an oral rinse, four to 10 times daily for an average of six to eight weeks beginning the first day of treatment. Data were reported for 171 of these patients who had completed folow up at the time the data were analyzed for this interim report.
The study showed that 95 percent of the patients reported favorable OM scores as measured by the percentages of patients indicating Grade 0 (no adverse effects or within normal limits), Grade 1 (mild) or Grade 2 (moderate) symptom severity.
The National Cancer Institute (NCI) clinical rating for OM (oral mucositis assessed during a clinical evaluation) of Grade 0 was evident in 61 percent of patients and Grade 1 clinical OM was seen in 20 percent. An NCI functional rating of OM (reflective of how OM affects diet, swallowing, gastrointestinal function and quality of life) of Grades 0 and 1 were reported in 81 percent of patients. Sixty-five percent of patients ranked their dysphagia symptoms (difficulty swallowing) as Grade 0, while 15 percent rated their symptoms as Grade 1. Grade 0 pain was reported by 61 percent of patients and 20 percent assessed their pain as Grade 1.
Out of 112 patients undergoing chemotherapy alone, 78 percent indicated a
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