MedDataX Logo

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

NCT ID: NCT06482034

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Radiation-Induced Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a randomized, controlled, interventional clinical trial conducted at Mansoura University Oncology Hospital. Fifty head and neck cancer patients receiving radiotherapy will be randomized into five groups of ten each. Group I will receive N-acetylcysteine (NAC) sachets (600mg) twice daily, Group II will receive zinc sulfate capsules (25mg) thrice daily, Group III will receive both NAC and zinc sulfate, and Group IV will receive NAC and zinc sulfate after mucositis onset. Group V, the control group, will receive standard care with normal saline mouthwash. The study aims to evaluate the efficacy of NAC, zinc sulfate, and their combination in treating radiotherapy-induced oral mucositis. Mucositis severity will be assessed using the WHO criteria for grading oral mucositis. Patients' consent and ethical approval will be obtained.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

N-acetyl cysteine sachets

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.

Group Type EXPERIMENTAL

Zinc sulfate

Intervention Type DRUG

zinc sulfate capsules

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.

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

N-acetyl cysteine sachets

Zinc sulfate

Intervention Type DRUG

zinc sulfate capsules

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.

Group Type EXPERIMENTAL

N-acetyl cysteine

Intervention Type DRUG

N-acetyl cysteine sachets

Zinc sulfate

Intervention Type DRUG

zinc sulfate capsules

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.

Group Type ACTIVE_COMPARATOR

saline mouth wash

Intervention Type DRUG

saline mouth wash

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-acetyl cysteine

N-acetyl cysteine sachets

Intervention Type DRUG

Zinc sulfate

zinc sulfate capsules

Intervention Type DRUG

saline mouth wash

saline mouth wash

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nadia Hamdy Ibrahim Mohamed Aref

B.D.S, M.S, Master Degree of Oral Medicine & Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nadia Aref, BDS, MS

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura university

Al Mansurah, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Kim HJ, Kang SU, Lee YS, Jang JY, Kang H, Kim CH. Protective Effects of N-Acetylcysteine against Radiation-Induced Oral Mucositis In Vitro and In Vivo. Cancer Res Treat. 2020 Oct;52(4):1019-1030. doi: 10.4143/crt.2020.012. Epub 2020 Jun 18.

Reference Type BACKGROUND
PMID: 32599978 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M02040230M

Identifier Type: -

Identifier Source: org_study_id