Clinical trial · Interventional
Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
NCT06354712CI-TRIAL-00084727recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck 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 (Ulcerative) Due to Radiation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Institutional standard care | Drug | — | UNRESOLVED |
| N-Acetyl-Cysteine with Institutional standard care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control arm
- description
- Standard Care
- interventionNames
- Drug: Institutional standard care
- type
- ACTIVE_COMPARATOR
- label
- Interventional arm
- description
- Standard Care plus NAC
- interventionNames
- Drug: N-Acetyl-Cysteine with Institutional standard care
Primary outcomes (1)
- measure
- Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults \>18 years diagnosed with squamous cell carcinoma of the head and neck scheduled to receive curative radiotherapy (Primary or postoperative) of at least 50 Gy with or without concurrent chemotherapy. 2. Individuals with healthy mucosa. 3. Adequate bone marrow function (Hemoglobin level ≥10 g/dL, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter). 4. Patients with ECOG performance ≤2 Exclusion Criteria: 1. History of chemotherapy or radiotherapy. 2. Signs of systemic infections. 3. Pregnant and lactating women. 4. Individuals receiving systemic analgesics. 5. Liver disorders and renal failure with eGFR \<30 ml/min/1.73m2 (by the MDRD equation). 6. Inability to follow instructions and complete the questionnaires.
References
Publications (0)
Data not yet available
No reference posted for this study.