Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution.
OBJECTIVE
CAM2028, a vehicle that forms a bioadhesive lipid barrier when applied to the oral mucosa, was developed as a carrier system for local delivery of benzydamine, an NSAID used for pain relief in oral mucositis. This trial compared the analgesic effect of CAM2028 plus benzydamine (CAM2028-benzydamine) with unmedicated CAM2028 (CAM2028-control) for the treatment of oral mucositis in patients with head-and-neck cancer.


METHODS
Thirty-eight study participants were enrolled during their 3rd to 4th week of radiation therapy. Participants were required to have symptomatic oral mucositis (WHO Grade 2 or above) at screening and pain scores of at least 6 on an 11-point Likert scale at screening and on each day before treatment with study medication. After undergoing radiation, patients were administered a single dose of CAM2028-control or CAM2028-benzydamine 2 days apart, in a randomized crossover fashion. Pain was assessed over the following 8 h.


RESULTS
With both treatments, patients experienced a mean 40 % decrease in pain intensity at 6 h (the primary study endpoint). Both treatments resulted in significant pain relief within 5 min of application that was evident during the entire 8-h assessment period. There was no difference in pain relief between the two interventions at any time point. Both treatments were safe and well tolerated.


CONCLUSIONS
CAM2028-benzydamine and CAM2028-control were both efficacious in reducing pain in patients with oral mucositis related to radiation therapy for head-and-neck cancer. Analgesic effects of both medications were immediate, clinically significant, and persistent for up to 8 h.
Department of Radiotherapy, Medical University, Sofia, Bulgaria.
Tatiana
T
Hadjieva
Eva
E
Cavallin-Ståhl
Margareta
M
Linden
Fredrik
F
Tiberg
D000328:Adult; D000368:Aged; D001591:Benzydamine / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000528:radiation effects; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010865:Pilot Projects; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D012826:Silicone Elastomers / Q000008:administration & dosage* / Q000009:adverse effects; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control
D012826:Silicone Elastomers; C545984:episil; D001591:Benzydamine