Clinical trial · Interventional
N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients
Effectiveness of N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (A Randomized Controlled Clinical Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Radiotherapy appears to be one of the most effective therapies in head and neck tumors, however, there are a lot of complications related to it. Oral Mucositis is one of the most common complications following radiotherapy. There are currently huge unmet needs for management of oral mucositis. It causes severe pain, reduces food intake and affects quality of life of the head and neck cancer patients .N-acetylcysteine (NAC) is a glutathione precursor which has an antioxidant property and protects against radiation therapy-induced free radical damage. NAC reduces the production of inflammatory markers which leads to decrease inflammation, treats oral mucositis and enhances quality of life of the patient. Aim: To evaluate the effectiveness of N-acetylcysteine and its formulated nanoparticles in treatment of radiotherapy induced oral mucositis in oral cancer patients .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional treatment | Drug | — | UNRESOLVED |
| N-acetylcysteine (NAC) spray | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test Group
- interventionNames
- Drug: N-acetylcysteine (NAC) spray
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- interventionNames
- Drug: Conventional treatment
Primary outcomes (2)
- measure
- Change in pain scores
- timeFrame
- Baseline,1,2,4,6 weeks
- description
- The Numerical Rating Scale (NRS-11):- where patients are asked to rate their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst possible pain
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with oral cancer by incisional biopsy histological examination. * Patients above the age of 20 years. * Patients receiving radiotherapy either as postoperatory (adjuvant) or as a definitive therapy in the treatment for oral cancer. * Patients with radiotherapy induced-oral mucositis. * Radiation dose ≥ 60 Gy which is responsible for oral mucositis development in oral cancer patients. Exclusion Criteria: * Patients diagnosed with any other type of cancer. * Patients with any systemic disease as diabetes, cardiovascular, liver disorders and kidney disorders. * Patients under anticoagulants such as warfarin, heparin or aspirin. * Patients with findings of any physical or mental abnormalities
References
Publications (1)
- DERIVEDEssam A, Domiaty SE, Attia N, Helal H, Meheissen M. N-acetylcysteine nano-spray versus conventional treatment in the management of radiotherapy-induced oral mucositis in oral cancer patients: a randomized clinical trial. BMC Oral Health. 2026 Mar 20;26(1):616. doi: 10.1186/s12903-026-07959-7. PMID 41862922