Effect of Gelclair™ in patients with erosive oral mucositis after allogeneic stem cell transplantation

Introduction: Oral mucositis (OM) in patients after allogeneic stem cells transplantation is significant nursing problem. Oral care with regular mouthwashes is standard approach in affected patients. In our setting, oral rinses with chlorhexidine, salvia, benzydamine, normal saline, bottled water or normal saline with local anesthetics are offered to patients with respect to their wish and preference. Gelclair is water-soluble gel containing polyvinylpyrrolidone to protect the mucosa and sodium hyaluronate to hydrate it. Adhering to the mucosal surface of the mouth, the Gelclair sooths oral lesions and coats the exposed nerve endings of the mucosa. The company claims that Gelclair provides rapid and durable pain relief. Goal: to verify effect of Gelclair in patients with erosive OM. Methods: patients with erosive OM (gr.2-4 WHO) after allogeneic stem cells transplantation. Prospective, non-sponsored, observational study. Gelclair used 3 times a day. OM assessed by WHO criteria. Gelclair tolerability assessed by VAS (1=outstanding, 3= indifferent, 5= repulsive). Results: in the period of 1-9/2008, 18 patients we included into this observation and analyzed. Conditioning regimens were: FLU/MEL (melphalan 140mg/[m.sup.2]) in 13/18 (72%) patients and BU/CY2 in 5/18 (28%). Incidence of maximum OM grade: gr.2 in 8/18 (44%), gr.3 in 9/18 (50%), gr.4 in 1/18 (6%). Duration of OM: median 11( 5-16) days. Duration of Gelclair usage: median 8(5-14) days. Gelclair tolerability: median 2(1-5). Oral intake: improved (16%), no difference (84%), worsened (0%). Pain relief experienced: outstanding (0%), good (22%), partial (22%), weak (44%), no effect (12%). Duration of pain relief: no (12%), up to 3 hours (83%), up to 5 hours (5%). In addition to Gelclair, in 66% patients systemic analgesic treatment was given, too. Conclusion: Gelclair proved to have individual effect with slight and short-term duration analgesic activity. Patients tolerated it quite well. No significant adverse events were observed. Gelclair can be individually offered to patients with assumption that it is likely to only partially comfort the oral pain. While OM affects also pharyngeal parts of mucosa and Gelclair was able to protect oral mucosa in our patients, the effect on improved oral intake could not be observed due to pain caused by pharyngeal mucositis during swallowing. Discussion: To get objective data, larger observational trial comparing Gelclair and other local agents would be necessary.