[Assessing the effectiveness of Gelclair® in the prevention and therapy of stomatitis in patients undergoing hematopoietic stem-cell transplantation: a randomized trial].
BACKGROUND
Chemotherapy-induced stomatitis is a major side effect of the treatment. Numerous approaches are described in the literature for the prevention and treatment of this complication.


OBJECTIVE
the aim was assess the effectiveness of Gelclair® in patients undergoing hematopoietic stem-cell transplantation in terms of reducing the incidence of stomatitis, stomatitis-pain and the severity of stomatitis


METHODS
Fifty-seven patients (28 control group and 29 experimental group) used a mouthwash 3 times a day and were evaluated by means of a specially-tailored form containing the following assessment items:stomatitis evaluation scale (WHO), VAS for pain and Likert-Scale for agreement.


RESULTS
61% of patients presented with stomatitis. No difference was observed between the two groups with regard to stomatitis grade throughout the observation period. Painful symptoms were observed in 54% subjects. No differences were observed in terms of average pain perception before the use of mouthwashes throughout the period of observation p=0.06. RESULTS showed a pain-relieving effect in the experimental group after using the mouthwash p=0.04.


CONCLUSIONS
Although Gelclair® had no influence on the onset and severity of stomatitis in transplanted patients, a significant benefit was observed in terms of pain control. Our study suggest the possibility to implementation the use of Gelclair® in clinical practice. However, further multicenter trials are needed to provide stronger evidence on the real usefulness of this product.
Professor of Nursing Science Università degli Studi di Firenze Corrispondence: l.rasero@unifi.it.
Laura
L
Rasero
Mauro
M
Marsullo
Alberto
A
Dal Molin
D000328:Adult; D004338:Drug Combinations; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011205:Povidone / Q000627:therapeutic use*; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
D004338:Drug Combinations; C439265:Gelclair; D006820:Hyaluronic Acid; D011205:Povidone