Effects of an oral mucosa protective formulation on chemotherapy- and/or radiotherapy-induced oral mucositis: a prospective study.
Adult
Aged
Antineoplastic Agents
/ adverse effects
Feasibility Studies
Female
Head and Neck Neoplasms
/ therapy
Hematopoietic Stem Cell Transplantation
Humans
Male
Middle Aged
Mouth Mucosa
/ drug effects
Pain
/ drug therapy
Pain Measurement
Prospective Studies
Quality of Life
Radiation Injuries
/ drug therapy
Silicone Elastomers
/ administration & dosage
Stomatitis
/ drug therapy
Treatment Outcome
Bioadhesive
Breakthrough pain
Deglutition
Hydrogel
Mucositis
Opioid analgesics
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
21 Jan 2022
21 Jan 2022
Historique:
received:
21
07
2021
accepted:
10
12
2021
entrez:
22
1
2022
pubmed:
23
1
2022
medline:
3
3
2022
Statut:
epublish
Résumé
Oral mucositis (OM) associated with cancer treatment not only impairs patients' quality of life but also causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of Episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of the pain-relieving effect, feeling during use, and adverse events or problems were evaluated. In total, 10 Japanese cancer patients with OM receiving chemotherapy, pretreatment therapy for hematopoietic stem cell transplantation, or radiation therapy for head and neck cancer were enrolled. A numerical rating scale (NRS) was used to assess oral pain intensity due to OM. Compared to baseline, the mean NRS began to decrease at 5 min after using Episil® (7.1 ± 1.4 to 4.6 ± 2.87; p = 0.264). A significant decrease was observed in the pain score after using Episil® compared with that before using Episil®, and this effect lasted up to 120 min. The protective effects of Episil® were observed 3-5 min after application. Some patients felt slight soreness or discomfort when applying Episil®. However, this discomfort due to Episil®'s stimulation was within the allowable range and transient. No adverse events were observed in any of the cases. The results of this prospective study showed that Episil® could be an effective treatment to relieve oral pain in Japanese patients with moderate to severe OM, and this newly approved product might adequately support patients' oral intake. University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) ( UMIN000031921 ).
Sections du résumé
BACKGROUND
BACKGROUND
Oral mucositis (OM) associated with cancer treatment not only impairs patients' quality of life but also causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of Episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of the pain-relieving effect, feeling during use, and adverse events or problems were evaluated.
METHODS
METHODS
In total, 10 Japanese cancer patients with OM receiving chemotherapy, pretreatment therapy for hematopoietic stem cell transplantation, or radiation therapy for head and neck cancer were enrolled.
RESULTS
RESULTS
A numerical rating scale (NRS) was used to assess oral pain intensity due to OM. Compared to baseline, the mean NRS began to decrease at 5 min after using Episil® (7.1 ± 1.4 to 4.6 ± 2.87; p = 0.264). A significant decrease was observed in the pain score after using Episil® compared with that before using Episil®, and this effect lasted up to 120 min. The protective effects of Episil® were observed 3-5 min after application. Some patients felt slight soreness or discomfort when applying Episil®. However, this discomfort due to Episil®'s stimulation was within the allowable range and transient. No adverse events were observed in any of the cases.
CONCLUSIONS
CONCLUSIONS
The results of this prospective study showed that Episil® could be an effective treatment to relieve oral pain in Japanese patients with moderate to severe OM, and this newly approved product might adequately support patients' oral intake.
TRIAL REGISTRATION
BACKGROUND
University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) ( UMIN000031921 ).
Identifiants
pubmed: 35062896
doi: 10.1186/s12885-021-09107-6
pii: 10.1186/s12885-021-09107-6
pmc: PMC8780715
doi:
Substances chimiques
Antineoplastic Agents
0
Silicone Elastomers
0
episil
0
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
90Informations de copyright
© 2021. The Author(s).
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