Using N-acetylcysteine to prevent mouth sores in head and neck cancer patients undergoing radiation therapy

Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.

This study is testing if N-acetylcysteine can help prevent painful mouth sores in adults with head and neck cancer who are getting radiation treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Mansoura University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Al Mansurah)
• Trial ID: NCT06354712 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the effectiveness of N-acetylcysteine in preventing oral mucositis, a painful condition that can occur in patients receiving radiotherapy for head and neck cancer. The study will be a prospective, randomized, controlled trial conducted at Mansoura University Hospital, where participants will receive either N-acetylcysteine alongside standard care or standard care alone. The trial aims to determine if N-acetylcysteine can reduce the incidence and severity of oral mucositis in this patient population. Eligible participants include adults diagnosed with squamous cell carcinoma of the head and neck who are scheduled for curative radiotherapy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with squamous cell carcinoma of the head and neck who are about to start curative radiotherapy.

Not a fit: Patients who have previously undergone chemotherapy or radiotherapy, or those with systemic infections or severe liver or kidney disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of painful oral mucositis in patients undergoing radiotherapy for head and neck cancer.

How similar studies have performed: While there have been studies exploring various interventions for oral mucositis, the specific use of N-acetylcysteine in this context is relatively novel and has not been extensively tested.

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.

Where this trial is running

Al Mansurah

• Clinical Oncology and Nuclear Medicine of Mansoura University Hospital — Al Mansurah, Egypt (Recruiting)

Study contacts

• Principal investigator: Mohamed el-Husseiny shams, Professor — Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
• Study coordinator: Reem Abou-Elezz, BSc

Conditions Oral Mucositis Due to Radiation; Oral Mucositis, Radiotherapy, N-acetylcysteine