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

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"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.

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 clinical OM rating of Grade 0 and 79 percent indicated a functional OM rating of Grade 0. Moreover, 23 percent of the 56 patients undergoing radiation therapy alone or in combination with chemotherapy (RT � chemo) indicated a clinical OM rating of Grade 0, and 34 percent indicated a functional OM rating of Grade 0. With regard to pain 79 percent of patients undergoing chemotherapy alone and 25 percent of RT � chemo-treated patients rated their pain as Grade 0. For dysphagia, eighty-two percent of chemotherapy-treated patients and 30 percent of those undergoing RT � chemo treatment reported a dysphagia Grade of 0.

These data confirm that early intervention with Caphosol reduces the occurrence and severity OM, dysphagia and oral pain in patients undergoing chemotherapy, radiation or combination therapy treatments for cancer.

Quality-of-Life Benefits in Patients with Head/Neck Cancer

Oral mucositis occurs in nearly all chemoradiation patients with HNC. Dr. Haas will present a subset analysis of data from 67 HNC patients from the study described above. She will present these data here tomorrow (May 17, 2008) in a poster (#446) entitled, "Supersaturated Electrolyte Oral Rinse Aids Quality of Life for Head/Neck Chemoradiation Patients." These data confirm high levels of patient and practitioner satisfaction with CAPHOSOL, suggestive of quality-of-life benefits. The poster reports that more than half (52 percent) of the HNC patients said they were "very satisfied" with CAPHOSOL in terms of pain relief and oral comfort. None of the HNC patients reported being unsatisfied with CAPHOSOL.

This study showed that among practitioners treating HNC patients, 16 percent of practitioners reported no signs of OM in their patients at the end of the study, and 70 percent assigned an "excellent or good" rating to CAPHOSOL because none of their patients required additional therapies. Ninety-six percent of the patients indicated they would recommend CAPHOSOL to other patients at high risk of OM.

"Considering that most patients with head and neck cancer experience oral mucositis, any improvements in quality of life for these patients is encouraging," said Dr. Haas. "CAPHOSOL is useful for oncology nurses and other healthcare practitioners in helping patients with oral pain and related symptoms of chemoradiation-induced oral mucositis."

Oral Mucositis: A Common and Debilitating Condition

Oral complications including mucositis and salivary gland dysfunction are common and often debilitating side effects of cancer therapy. OM is estimated to affect more than 400,000 cancer patients each year. OM affects approximately 40 percent of cancer patients who receive chemotherapy, more than 70 percent of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.

Oral mucositis usually manifests itself within seven to 14 days after initiation of therapy. Initial signs and symptoms include redness, swelling and ulceration of the mucosa. Oral mucositis can cause mouth pain, xerostomia (dryness of the mouth or throat), difficulty eating and drinking, as well as difficulty with speech; these effects can significantly impact a patient's weight, mood and physical functioning. Severe ulceration may cause breaks in the mucosa, which can then become susceptible to oral opportunistic infections, possibly resulting in bacteremia (the presence of bacteria in the blood), sepsis (the presence of pathogenic microorganisms in the blood) or other potentially fatal complications. The economic impact of mucositis can be significant, as the need for prolonged hospital stays, nutritional therapy and treatments for pain and infection can drive up the costs of therapy.

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