Clinical Case
NaSiL Oral Gel Liquid Oral Dressing
Clinical Trial
IRB No：NTUH-REC No.: 202001014DSC
Title of protocol ：「Explore the efficacy of Oral Gel (NaSIL) on the improvement of Radiotherapy/Chemotherapy-induced Oral Mucositis’condition and patients’ Oral Health-Related Quality of Life 」
Trial/Research Institution：National Taiwan University Hospital
Background：
Oral mucositis (OM) is an extremely common side effect of radiation therapy and chemotherapy, with severe cases causing significant pain to patients and affecting their dietary intake and quality of life. It can lead to weight loss, immune suppression, oral infections, and in severe cases, treatment interruptions that prolong cancer therapy and reduce treatment efficacy, consequently increasing treatment costs. Head and neck cancer patients undergoing concurrent chemoradiotherapy (CCRT) have a high OM incidence of up to 96.9%, with 61.3% experiencing severe grades (3-5) of mucositis. (Vanita Noronha et al, 2021)
Purpose :
The purpose of this study is to evaluate the efficacy of co-polyacrylate silver salt/Polyvinylpyrrolidone-based liquid oral dressing (NaSiL Oral Gel) in improving the symptomatic relief of CCRT-induced mucositis and oral dysfunction in neck and head cancer patients, and also aim to investigate whether using liquid oral dressing as a mouthwash for oral hygiene can enhance oral health-related quality of life (OHRQoL) for patients with CCRT-induced mucositis.
Cllinical Trial Methods
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Study Design:
This was a prospective, randomized, single-blind, parallel-arm, and single-center study involving patients with head and neck cancer treated with CCRT in the Department of Oncology, National Taiwan University Hospital.
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Recruiting Criteria
Neck & Head cancer patients underwent concurrent chemoradiotherapy (CCRT) and having oral mucositis grade 2 or higher. The patients will be randomly assigned into the test group and the control group after recruiting.
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Data Collection Protocol
Both groups followed the clinical practice guidelines for mucositis management from the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO). However, in the test group, 15g of NaSiL Oral Gel was added for rinsing after oral hygiene. Mucositis grade and oral function data collected from participants at enrollment were used as baseline. Subsequently, data on mucositis grade and oral function were collected weekly for four consecutive weeks during the course of radiotherapy, serving as post-treatment measurements.
Results：(J Formos Med Assoc. 2023 Aug;122(8):723-730)
ults showed that polyacrylate silver salt oral gel had better effect for relieving the oral mucositis. There were statistically significant differences in OM scores (1.59 vs. 2.8, p<0.0001) between the test group and the control group.
gargling with NaSiL Oral Gel in Test group could keep a sustained improvement on the severity of OM, however, the data in Control group did not show this trend.
Publish research paper and thesis
Chin, HL., Chung, KP., Liu, HC., Chen, RS., Chang, HH., Chen, MH.. Efficacy of polyacrylate silver salt/polyvinylpyrrolidone-based liquid oral gel in management of concurrence chemoradiotherapy-induced oral mucositis. J Formos Med Assoc. 2023 Aug;122(8):723-730. doi: 10.1016/j.jfma.2022.12.007. Epub 2023 Jan 7. PMID: 36623972.
Chin, HL., Chung, KP., Chen, MH.. To investigate the effect of CCRT-induced OM improvement on the healthy QoL in head and neck cancer patients under the intervention of PSS liquid oral dressing: A stratified RCT. 2022
