NCT06482034

Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The majority of individuals diagnosed with head and neck cancer, who undergo radiotherapy or concurrent Chemoradiotherapy, experience oral mucositis. Our research focuses on investigating the preventive and therapeutic impact of N-acetylcysteine and zinc in managing radiotherapy-induced oral mucositis.

Detailed description

almost all head and neck cancer patients who to receive radiotherapy or concurrent chemotherapy suffer from oral mucositis. Oral mucositis (OM) is associated with pain, difficulty in eating, dysphagia, and the need for enteral or parenteral nutrition, increased opioid consumption or even interruptions to cancer therapy. In immunosuppressed patients, OM is associated with bacteremia, increased inpatient hospitalization duration and higher 100-day mortality. Treatments to manage cancer, such as radiotherapy, generates reactive oxygen species (ROS) that target neoplastic cell DNA resulting in cell damage and death. ROS from these therapies also indiscriminately target healthy non-neoplastic DNA. Zinc carries out its antioxidant function in two ways: Reducing the concentration of oxidant agents and protecting structures and macromolecules suffer from oxidant agent. N-acetylcysteine is an aminothiol and precursor to glutathione (GSH), glutathione in its reduced form is the most powerful intracellular antioxidant, thereby protecting against radiation-induced free radical damage. our study is A randomized, controlled, parallel clinical trial that will be applied at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to investigate the prophylactic and therapeutic effect of N-acetylcysteine and zinc on radiotherapy induced oral mucositis in Head and Neck cancer patients.

Conditions

• Radiation-Induced Mucositis

Interventions

Type	Name	Description
DRUG	N-acetyl cysteine	N-acetyl cysteine sachets
DRUG	Zinc sulfate	zinc sulfate capsules
DRUG	saline mouth wash	saline mouth wash

Timeline

• Start date: 2023-06-28
• Primary completion: 2024-09-30
• Completion: 2024-11-30
• First posted: 2024-07-01
• Last updated: 2024-12-31

Locations

1 site across 1 country: Egypt