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

NCT06482034 | Completed Phase 2 DMC

• 1 other identifier: M02040230M
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-Induced Mucositis

Outcome Measures

Primary Outcomes (3)

• Incidence of Radiotherapy-Induced Oral Mucositis

  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

  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

  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.

Study Arms (5)

Group 1

EXPERIMENTAL

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

Group2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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; Drug: Zinc sulfate

Group 4

EXPERIMENTAL

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; Drug: Zinc sulfate

Group 5

ACTIVE COMPARATOR

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

Interventions

N-acetyl cysteine DRUG

N-acetyl cysteine sachets

Group 1; Group 3; Group 4

Zinc sulfate DRUG

zinc sulfate capsules

Group 3; Group 4; Group2

saline mouth wash DRUG

saline mouth wash

Group 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32599978 BACKGROUND

MeSH Terms

Interventions

Acetylcysteine; Zinc Sulfate

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Sulfates; Sulfuric Acids; Sulfur Acids; Inorganic Chemicals; Zinc Compounds

Study Officials

• Nadia Aref, BDS, MS

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S, M.S, Master Degree of Oral Medicine & Periodontology

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 1, 2024
• Study Start: June 28, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)