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CAPHOSOL results in minimal oral mucositis and pain in head/neck cancer patients

SEATTLE, Wash., November 15, 2008 New data show that CAPHOSOL (, an advanced electrolyte solution, results in low rates of oral mucositis and pain in patients with head and neck (HN) cancer who are undergoing chemotherapy and radiation therapy. The data, which were presented today at the Advanced Practice Nursing Conference of the Oncology Nursing Society (ONS), demonstrate that use of CAPHOSOL from the initiation of cancer treatment results in a low incidence of oral mucositis (OM) and is associated with high levels of patient and physician satisfaction and medication compliance.

The findings are the latest to suggest that CAPHOSOL use can benefit cancer patients in the management of OM and related symptoms.

"For cancer patients undergoing chemotherapy and radiation therapy, oral mucositis can be one of the more common and most dreaded complications of treatment, with a profound impact on quality of life," said principal investigator Marilyn L. Haas, PhD, RN, CNS, ANP-C, a nurse practitioner at Carolina Clinical Consultant in Asheville, N.C. "Oral mucositis results from erosion of epithelial cells in the oral cavity -- cells lining the surface of the throat and esophagus -- during therapy. The condition can cause severe pain, making it difficult for patients to eat and swallow food, while leaving them more susceptible to infection. In our registry, patients and physicians report that CAPHOSOL helps to improve quality of life while limiting the occurrence and severity of oral mucositis."

Dr. Haas and colleagues reported data from 68 patients with HN cancer enrolled in an open-label, observational registry maintained at 26 treatment centers in the U.S. The patients were considered at high risk of developing OM based on the nature of the cancer treatments they received. Most of the patients were male (74 percent) and Caucasian (85 percent). Radiation therapy was administered to 22 percent of the patients, chemotherapy to 12 percent, and a combination of the two types of therapy to 66 percent. All participating patients received CAPHOSOL, administered as an oral rinse, four to 10 times daily for 8 weeks for radiation therapy or 2 cycles if receiving chemotherapy, beginning on the first day of either treatment.

Low rates of OM were reported in CAPHOSOL-treated patients. Thirteen percent did not develop OM, 36 percent had Grade 1 (mild) OM and 33 percent had Grade 2 (moderate) disease. Grades 3 (severe) and 4 (life-threatening or disabling) OM occurred in only 16 percent and two percent of patients, respectively.

CAPHOSOL use also appeared to limit the incidence of oral pain and dysphagia (difficulty swallowing). Grades 2 (moderate) and 3 (severe) pain were experienced by 38 percent and 18 percent of patients, respectively, with no Grade 4 (disabling) pain reported. At Week 3 of the study, nearly half (46 percent) of the study participants did not require opioid pain medication, and more than one-third (36 percent) did not require opioids at Week 8. No dysphagia was reported in 18 percent of the patients; of those who did experience this effect, 21 percent had Grade 1 (mild), 36 percent had Grade 2 (moderate), 25 percent had Grade 3 (severe), and none experienced Grade 4 (disabling) dysphagia.

CAPHOSOL users reported high levels of satisfaction with this treatment, as did their physicians. Among patients, 79 percent described themselves as "satisfied" or "very satisfied" with CAPHOSOL, and 78 percent of physicians characterized the results with CAPHOSOL as satisfactory, good or excellent.

Compliance with CAPHOSOL treatment was very high among study participants. Nearly all patients rinsed with CAPHOSOL at least once daily for 96% of the days and at least four times daily for 76% of the days. Only four patients (7 percent) interrupted their chemoradiation regimen due to OM; none of these interruptions lasted longer than seven days. Only two patients discontinued CAPHOSOL treatment, one due to an aversion to the taste and the other due to an increase in the level of pre-existing nausea.

"The results of the present study add to a growing body of evidence supporting the use of CAPHOSOL from the beginning of chemoradiation therapy, as this rinse decreases the incidence and severity of oral mucositis," said Dr. Haas. "The high levels of patient and physician satisfaction, as well as high rates of compliance with CAPHOSOL treatment, suggest that this rinse can be included in oral care guidelines with confidence."

The estimated incidence of OM among patients with cancers of the head or neck receiving radiation therapy involving the oral cavity is 97%. Severe (grade 3/4) OM is a frequent complication.

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.

From the initiation of cancer therapy, breakdowns begin to occur below the surface of the skin in the mouth (oral mucosa). Visible signs of oral mucositis can usually be seen 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.


Contact: Anna Brodetsky

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