RecruitingPhase 2

Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.

Egypt50 participantsStarted 2024-04-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.

Timeframe: 8 weeks

Trial details

NCT IDNCT06354712

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

Contact for this trial

Reem Abou-Elezz, BSc

+201065396455 reemabouelezz@mans.edu.eg

View on ClinicalTrials.gov More Oral Mucositis (Ulcerative) Due to Radiation trials