Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 80

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

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

Run by Mansoura University · NCT06354712 · Data updated 2026-11-12

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.

More Radiation-induced Oral Mucositis trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment50 (estimated)
SponsorMansoura University
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Al Mansurah)
StatusRecruiting
StartedApril 4, 2024
Main results expectedMarch 1, 2025
Study endsMarch 1, 2025
Registry record updatedJanuary 15, 2025
Trial IDNCT06354712 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: reemabouelezz@mans.edu.eg
  • Phone: +201065396455

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.