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

December 30, 2024 updated by: Nadia Hamdy Ibrahim Mohamed Aref, Mansoura University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Intervention Type: Drug Intervention Name: N-acetylcysteine (NAC) Other Intervention Names: NAC Intervention Description: Patients will receive N-acetylcysteine sachets (600mg) twice daily. They will dissolve the NAC sachet in a cup of water, gargle for 60 seconds, and swallow it. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule.
Drug: N-acetyl cysteine
N-acetyl cysteine sachets
Experimental: Group2
Arm 2 Intervention Type: Drug Intervention Name: Zinc sulfate Other Intervention Names: Zinc Intervention Description: Patients will receive zinc sulfate capsules (25mg) thrice daily at 8-hour intervals. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule.
Drug: Zinc sulfate
zinc sulfate capsules
Experimental: Group 3
Arm 3 Intervention Type: Combination Product Intervention Name: N-acetylcysteine (NAC) and zinc sulfate Other Intervention Names: NAC and Zinc Intervention Description: Patients will receive N-acetylcysteine sachets (600mg) twice daily and zinc sulfate capsules (25mg) thrice daily. They will dissolve the NAC sachet in a cup of water, gargle for 60 seconds, and swallow it. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule.
Drug: N-acetyl cysteine
N-acetyl cysteine sachets
Drug: Zinc sulfate
zinc sulfate capsules
Experimental: Group 4
Intervention Type: Combination Product Intervention Name: N-acetylcysteine (NAC) and zinc sulfate after mucositis onset Other Intervention Names: NAC and Zinc post-mucositis Intervention Description: Patients who already began their radiotherapy and developed oral mucositis will receive N-acetylcysteine sachets (600mg) twice daily and zinc sulfate capsules (25mg) thrice daily. They will dissolve the NAC sachet in a cup of water, gargle for 60 seconds, and swallow it. The treatment will continue for 2 weeks after the completion of the radiotherapy schedule.
Drug: N-acetyl cysteine
N-acetyl cysteine sachets
Drug: Zinc sulfate
zinc sulfate capsules
Active Comparator: Group 5
Intervention Type: Other Intervention Name: Standard care (normal saline mouthwash) Other Intervention Names: Saline mouthwash Intervention Description: Patients will receive the institutional standard care, which is a normal saline mouthwash. The treatment will start 3 days before the beginning of radiotherapy and continue for 2 weeks after the completion of the radiotherapy schedule. Patients who develop any grade of oral mucositis will be treated according to the institutional standard treatment protocol.
Drug: saline mouth wash
saline mouth wash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of radiotherapy to 2 weeks after the completion of radiotherapy.
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.
From the start of radiotherapy to the onset of oral mucositis, monitored daily during radiotherapy and up to 2 weeks after completion of radiotherapy.
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.
Assessed weekly during radiotherapy and up to 2 weeks after the completion of radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Nadia Aref, BDS, MS, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02040230M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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