Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4469899
- author
- Hadjieva, Tatiana ; Cavallin-Ståhl, Eva LU ; Linden, Margareta and Tiberg, Fredrik
- organization
- publishing date
- 2014
- 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
- pmid:24442926
- 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
- 2016-04-01 13:44:17
- date last changed
- 2022-02-11 22:37:45
@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}},
keywords = {{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 = {{https://lup.lub.lu.se/search/files/3563088/5147904}},
doi = {{10.1007/s00520-014-2117-3}},
volume = {{22}},
year = {{2014}},
}