CAPHOSOL relieves oral mucositis and improves quality-of-life in cancer patients

New data underscore the utility of CAPHOSOL in treating oral mucositis

PHILADELPHIA, May 16, 2008 – New data show that CAPHOSOL® (www.caphosol.com), an advanced electrolyte solution, relieves painful oral mucositis (OM) and improves quality of life for cancer patients undergoing chemotherapy and radiation therapy. These data will be reported in two separate presentations, one today in an oral podium presentation and one tomorrow as a poster session, at the 33rd Annual Congress of the Oncology Nursing Society (ONS). These data confirm that CAPHOSOL is a useful tool to help oncology nurses and other healthcare professionals in the management of OM and related symptoms, particularly in patients with head and neck cancer and those receiving chemotherapy.

One of the two abstracts including this data, ONS Abstract #2757, "Supersaturated Electrolyte Oral Rinse Aids Quality of Life for Head/Neck Chemoradiation Patients" (Haas, ML), was selected by an ONS Expert Panel as one of the Top Ten Best Supportive Care abstracts at the ONS 2008 Congress.

“Oral mucositis is a painful, common side effect experienced by cancer patients receiving chemotherapy and radiation therapy,” commented principal investigator Marilyn L. Haas, PhD, RN, CNS, ANP-C, Nurse Practitioner, Mountain Radiation Oncology, Asheville, N.C. “As layers of epithelial cells in the oral cavity (cells lining the surface of the throat and esophagus) are eroded during therapy, patients often experience severe pain, are more prone to infection and have difficulty eating and swallowing. Our research concludes that CAPHOSOL, a supersaturated electrolyte oral rinse, should be introduced early in the course of cancer therapy for patients at high risk of oral mucositis because it minimizes the onset and severity of symptoms.”

The rate of severe oral mucositis (NCI Clinical OM Grade 3-4) reported by head and neck cancer patients using CAPHOSOL in this study was 11% (Grade 3) and 2% (Grade 4). Historically, the incidence of severe OM in head and neck cancer patients receiving radiation typically ranges from 34% - 56%, depending upon the specific type of treatment.

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.