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

Phase 2

Completed

• Conditions: Radiation-Induced Mucositis
• Interventions: Drug: N-acetyl cysteine; Drug: saline mouth wash; Drug: Zinc sulfate

• Registration Number: NCT06482034
• Lead Sponsor: Mansoura University

Brief 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.

Study Timeline

• Study Start: 2023-06-28
• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-30
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	N-acetyl cysteine	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 4	N-acetyl cysteine	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 1	N-acetyl cysteine	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 5	saline mouth wash	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.
Group2	Zinc sulfate	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 3	Zinc sulfate	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 4	Zinc sulfate	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.

Primary Outcome Measures

Name	Time	Method
Time to Onset of Oral Mucositis	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.
Incidence of Radiotherapy-Induced Oral Mucositis	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.
Severity of Oral Mucositis	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.

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Egypt