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

Mansoura University

Status and phase: Enrolling; Phase 2

Conditions: Oral Mucositis (Ulcerative) Due to Radiation

Treatments: Drug: Institutional standard care; Drug: N-Acetyl-Cysteine with Institutional standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT06354712

2024-45

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Control arm

Other group

Description:

Standard Care

Treatment:

Drug: Institutional standard care

Interventional arm

Active Comparator group

Description:

Standard Care plus NAC

Treatment:

Drug: N-Acetyl-Cysteine with Institutional standard care