RecruitingPhase 2NCT06354712
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.
Sponsor
Mansoura University
Enrollment
50 participants
Start Date
Apr 4, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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.
- Individuals with healthy mucosa.
- Adequate bone marrow function (Hemoglobin level ≥10 g/dL, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter).
- Patients with ECOG performance ≤2
Exclusion Criteria6
- History of chemotherapy or radiotherapy.
- Signs of systemic infections.
- Pregnant and lactating women.
- Individuals receiving systemic analgesics.
- Liver disorders and renal failure with eGFR \<30 ml/min/1.73m2 (by the MDRD equation).
- Inability to follow instructions and complete the questionnaires.
Interventions
DRUGN-Acetyl-Cysteine with Institutional standard care
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)
DRUGInstitutional standard care
Benzydamine Mouthwash
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06354712