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NCT Number: NCT06482034

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

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.

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Key information

Conditions

Radiation-Induced Mucositis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura university

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria

Inclusion criteria

  • Patients aged 18 years or older.
  • Patients diagnosed with head and neck cancer.
  • Patients are recommended for treatment with radiotherapy with a minimum dose of 20 Gy.

Exclusion criteria

  • Pregnancy and lactating women.
  • Cigarette smoker patients.
  • Patients with severe comorbid illnesses or immunocompromised status.
  • Patients receiving induction chemotherapy or those with previous head and neck radiotherapy. Patients using Amifostine during radiotherapy.

Treatment and study plan

N-acetyl cysteine

Drug

N-acetyl cysteine sachets

zinc sulfate

Drug

zinc sulfate capsules

saline mouth wash

Drug

saline mouth wash

Primary outcomes

  1. Incidence of Radiotherapy-Induced Oral Mucositis

    Time frame: From the start of radiotherapy to 2 weeks after the completion of radiotherapy.

    The incidence of any grade of oral mucositis will be measured in each group. This will be evaluated by recording the number of patients who develop oral mucositis during and after radiotherapy treatment.

  2. Time to Onset of Oral Mucositis

    Time frame: From the start of radiotherapy to the onset of oral mucositis, monitored daily during radiotherapy and up to 2 weeks after completion of radiotherapy.

    The time from the start of radiotherapy to the onset of any grade of oral mucositis in groups I, II, III, and V (control group). This will be measured by tracking the number of days until the first appearance of mucositis symptoms.

  3. Severity of Oral Mucositis

    Time frame: Assessed weekly during radiotherapy and up to 2 weeks after the completion of radiotherapy.

    The severity of oral mucositis will be measured using the World Health Organization (WHO) criteria for grading oral mucositis, which includes objective symptoms (redness, edema, wound development) and subjective symptoms (dysphagia, mucosal severity). Mucositis will be classified into grades:

    Grade 0: No change or erythema without pain. Grade 1: Pain with or without erythema, no ulcers. Grade 2: Oral erythema and ulcers, but the patient can eat solid and liquid food.

    Grade 3: Oral erythema and ulcers, the patient can eat only liquid/puree food. Grade 4: Severe oral ulcers; patient cannot eat solid or liquid food.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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