N-acetylcysteine nano-spray versus conventional treatment in the management of radiotherapy-induced oral mucositis in oral cancer patients: a randomized clinical trial.
- 2026-03-20
- BMC oral health 26(1)
- Alaa Essam
- Shahira El Domiaty
- Nahed Attia
- Hala Helal
- Mohamed Meheissen
- PubMed: 41862922
- DOI: 10.1186/s12903-026-07959-7
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 20
- Population
- 40 oral cancer patients undergoing radiotherapy
- Methods
- randomized clinical study, 1:1 ratio to receive either NAC nano-spray (n=20) or conventional therapy (n=20) for six weeks
- Duration
- six weeks
Background
Radiation-induced oral mucositis (RIOM) is a common and debilitating complication of radiotherapy in oral cancer patients, significantly impairing quality of life and potentially interrupting treatment. This study evaluated the therapeutic efficacy of N-acetylcysteine (NAC) nano-spray in managing RIOM, with particular emphasis on mucositis severity, quality of life, and serum gastrin-17 levels.Materials and methods
In this randomized clinical study, 40 oral cancer patients undergoing radiotherapy were allocated in a 1:1 ratio to receive either NAC nano-spray (n = 20) or conventional therapy (n = 20) for six weeks. Mucositis severity was assessed using the World Health Organization (WHO) Oral Mucositis Severity Scale, and quality of life was evaluated using the Oral Health Impact Profile (OHIP-14). Serum gastrin-17 levels were measured before and after treatment.Results
Patients treated with NAC nano-spray demonstrated a significant reduction in WHO mucositis grades and significantly improved OHIP-14 scores compared with the control group (p < 0.05). Additionally, a significant increase in serum gastrin-17 levels was observed in the NAC group relative to conventional therapy (p < 0.05). These effects were evident during radiotherapy and at the end of treatment.Conclusions
N-acetylcysteine nano-spray appears to be an effective therapeutic option for the management of RIOM, reducing mucositis severity and improving quality of life in oral cancer patients.Trial registration
The trial was registered at Clinical Trials .gov on 24/7/2025, registration number: (NCT07082621).Research Insights
significantly improved OHIP-14 scores compared with the control group (p < 0.05)
- Effect
- Beneficial
- Effect size
- Small
a significant increase in serum gastrin-17 levels was observed in the NAC group relative to conventional therapy (p < 0.05)
- Effect
- Beneficial
- Effect size
- Small
Patients treated with NAC nano-spray demonstrated a significant reduction in WHO mucositis grades
- Effect
- Beneficial
- Effect size
- Small