Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution

Support Care Cancer. 2014 Jun;22(6):1557-62. doi: 10.1007/s00520-014-2117-3. Epub 2014 Jan 18.


Purpose: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Benzydamine / administration & dosage*
  • Benzydamine / adverse effects
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Head and Neck Neoplasms / radiotherapy*
  • Humans
  • Male
  • Middle Aged
  • Mouth Mucosa / drug effects
  • Mouth Mucosa / radiation effects
  • Pain / drug therapy*
  • Pain / etiology
  • Pilot Projects
  • Radiation Injuries / drug therapy*
  • Radiation Injuries / etiology
  • Radiation Injuries / prevention & control
  • Silicone Elastomers / administration & dosage*
  • Silicone Elastomers / adverse effects
  • Stomatitis / drug therapy*
  • Stomatitis / etiology
  • Stomatitis / prevention & control


  • Silicone Elastomers
  • episil
  • Benzydamine