NCT06354712 Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
| NCT ID | NCT06354712 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mansoura University |
| Condition | Oral Mucositis (Ulcerative) Due to Radiation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2025-03-01 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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.