Clinical trial

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

NCT06482034

Name

M02040230M

Description

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.

Trial arms

Trial start

2023-06-28

Estimated PCD

2024-09-01

Trial end

2024-11-01

Status

Recruiting

Phase

Early phase I

Treatment

N-acetyl cysteine

N-acetyl cysteine sachets

Arms:

Group 1, Group 3, Group 4

Zinc sulfate

zinc sulfate capsules

Arms:

Group 3, Group 4, Group2

saline mouth wash

Arms:

Group 5

Size

Primary endpoint

Incidence of Radiotherapy-Induced Oral Mucositis

From the start of radiotherapy to 2 weeks after the completion of radiotherapy.

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.

Severity of Oral Mucositis

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

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.", 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-07-01

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product