Background: Oral mucositis (OM) is one of the most common side effect of HSCT due to high dose chemotherapy. Mel is widely used in conditioning regimen known to have toxicity on the mucosa which can lead to complications. No oral solution has been shown to be superior to the other in the treatment of OM. Orasol has been recently introduced in the clinical area as nutritional supplement with antinflammatory, analgesic and antifungal activity with no alcohol so can be swallowed,allowing patient(pt)compliance and with activity on the esophageal mucosa.
Primary objective: compare the efficacy between treatment with Orasol to Benzidamine in the OM prophylaxis in pt undergoing aHSCT following HDMel. Secondary objective :to confront outcomes related to use of supportive drugs and days of hospitalization.
Methods: We have performed a retrospective analysis on pts receiving aHSCT from 2011 to 2012 following a Mel containing conditioning regimen and receiving Benzidamine (Group 1) or Orasol (Group 2). Each pt had a daily evaluation of OM according to WHO criteria. The treatment with both solutions was started the day before the conditioning regimen until the end of hospitalization.
Results: We reviewed data of 32 pt.16 pt received treatment with Benzidamine and 16 pt received treatment with Orasol. 7 pts in Group1 had OM WHO grade 0 and 9 pts had a OM grade1.At the end of treatment 1 pt had grade 0 OM,11 pts grade 1;3 pts grade2and 1 pt grade 3. In Group2,at the beginning of treatment 8 pts had grade 0 OM;8 pts had grade1,while at the end of treatment 14 pts had OM grade 0 and 2 had G1. The prophylactic antifungal therapy was given to all pts;6 pts from Group1 (37.5%) received antifungal therapy with liposoma Amfotericine B for worsening of mucositis while in group 2 the antifungal therapy was given to 2 pts. (12.5%). Morphine was administered to 7 pts from Group1 (43,75%) and to only 1 pt (6,25%) from Group2. In Group 1 the median duration of hospitalization was 20,9 days, while in Group2 it was 19,7days.
Conclusions: In our sample we observed that prophylactic treatment with Orasol appears to allow a better protection of oral mucosa compared with Benzidamine allowing, in case of mucositis reduction in the use of systemic analgesic and antifungal therapy. No significant difference was observed in days of hospitalization.