Treatment of Oral Mucositis with CAPHOSOL

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We have people from other sarcoma boards reporting that they use CAPHOSOL to combat Oral mucositis and it helps to them.

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.

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.
About CAPHOSOL

CAPHOSOL is an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating OM caused by radiation or high dose chemotherapy. CAPHOSOL, a U.S. patented prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. Patients restricted to a low sodium diet should consult their physician before use. Patients should avoid eating or drinking at least 15 minutes after use.

As part of its commitment to advancing the treatment and care of cancer patients, Cytogen launched CARE OM™ (www.careom.com) a Web-based education and support center for patients and caregivers seeking to learn more about OM and CAPHOSOL. In addition to oral mucositis educational material and support information, visitors to CARE OM can also download an OM brochure or request it by mail. For more information about CAPHOSOL, visit www.caphosol.com or call (800) 833-3533.