Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06354712

Study Evaluating N-acetylcysteine to Prevent Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients

Led by Mansoura University · Updated on 2025-01-15

50

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a Phase 2 randomized controlled trial at Mansoura University Hospital to evaluate the effectiveness of N-acetylcysteine in preventing oral mucositis caused by radiotherapy in patients with head and neck squamous cell carcinoma. This study focuses on patients receiving curative radiotherapy of at least 50 Gy, with or without chemotherapy, aiming to reduce the severity of oral mucositis during treatment. Participants are divided into two groups: one receiving N-acetylcysteine along with the institutional standard care, which includes Benzydamine mouthwash, and the other receiving only the institutional standard care. N-acetylcysteine is a strong antioxidant and anti-inflammatory drug that acts as a precursor to glutathione, the body's natural antioxidant. Treatments are administered throughout the radiotherapy period. During the 8-week study, patients will be monitored weekly to assess the occurrence and severity of oral mucositis using the World Health Organization scale. Researchers will also evaluate safety and treatment adherence. The study includes regular clinical evaluations and laboratory tests to monitor patients' health and response to the interventions.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years diagnosed with squamous cell carcinoma of the head and neck scheduled for curative radiotherapy of at least 50 Gy, with or without chemotherapy
  • Healthy oral mucosa at the start of the study
  • Adequate bone marrow function: Hemoglobin 10 g/dL, platelet count 75  103/microliter, and absolute neutrophil count 1.5  103/microliter
  • ECOG performance status 2 or better
Not Eligible

You will not qualify if you...

  • History of chemotherapy or radiotherapy treatments
  • Signs of systemic infections
  • Pregnant or lactating women
  • Current use of systemic analgesics
  • Liver disorders or renal failure with eGFR less than 30 ml/min/1.73m2
  • Inability to follow instructions or complete questionnaires

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Trial Site Locations

Total: 1 location

1

Clinical Oncology and Nuclear Medicine of Mansoura University Hospital

Al Mansurah, Egypt

Actively Recruiting

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Research Team

R

Reem Abou-Elezz, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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