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

Hadjieva, Tatiana; Cavallin-Ståhl, Eva LU ; Linden, Margareta and Tiberg, Fredrik (2014) In Supportive Care in Cancer 22(6). p.1557-1562
Abstract
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. 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... (More)
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. 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. 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. 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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Oral mucositis, Head-and-neck neoplasms, Analgesia, Benzydamine, Crossover studies, Treatment, Rinses, Coating agents, Radiation
in
Supportive Care in Cancer
volume
22
issue
6
pages
1557 - 1562
publisher
Springer
external identifiers
  • wos:000335775000014
  • scopus:84902357599
ISSN
0941-4355
DOI
10.1007/s00520-014-2117-3
language
English
LU publication?
yes
id
fd6ff735-4eb2-40b9-9958-b22e0a9273cf (old id 4469899)
date added to LUP
2014-07-01 07:41:41
date last changed
2017-07-02 03:58:48
@article{fd6ff735-4eb2-40b9-9958-b22e0a9273cf,
  abstract     = {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. 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. 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. 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.},
  author       = {Hadjieva, Tatiana and Cavallin-Ståhl, Eva and Linden, Margareta and Tiberg, Fredrik},
  issn         = {0941-4355},
  keyword      = {Oral mucositis,Head-and-neck neoplasms,Analgesia,Benzydamine,Crossover studies,Treatment,Rinses,Coating agents,Radiation},
  language     = {eng},
  number       = {6},
  pages        = {1557--1562},
  publisher    = {Springer},
  series       = {Supportive Care in Cancer},
  title        = {Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution},
  url          = {http://dx.doi.org/10.1007/s00520-014-2117-3},
  volume       = {22},
  year         = {2014},
}