Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: N-Acetyl-Cysteine with Institutional standard care, Institutional standard care.
- Who it may be relevant to
- Registry conditions: Oral Mucositis (Ulcerative) Due to Radiation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
Overview
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.
Interventions
- Drug N-Acetyl-Cysteine with Institutional standard care
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione) - Drug Institutional standard care
Benzydamine Mouthwash
Primary outcome measures
- Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis. [Time frame: 8 weeks]
Secondary outcome measures (5)
- Time to develop oral mucositis with grade ≥ 2. [Time frame: 8 weeks]
- Duration of oral mucositis with grade ≥ 2. [Time frame: 8 weeks]
- Pain assessed by Visual Analog Scale (VAS). [Time frame: 8 weeks]
- Functional oral intake scale [Time frame: 8 weeks]
- Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4 [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Clinical Oncology and Nuclear Medicine of Mansoura University Hospital — Al Mansurah
Identifiers
NCT: NCT06354712 · 2024-45