Clinical trial NCT06482034: Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis
Official title: Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiation-Induced Mucositis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Radiotherapy-Induced Oral Mucositis
timeFrame: From the start of radiotherapy to 2 weeks after the completion of radiotherapy.
measure: Time to Onset of Oral Mucositis
timeFrame: From the start of radiotherapy to the onset of oral mucositis, monitored daily during radiotherapy and up to 2 weeks after completion of radiotherapy.
measure: Severity of Oral Mucositis
timeFrame: Assessed weekly during radiotherapy and up to 2 weeks after the completion of radiotherapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: Mansoura University
name: Nadia Aref, BDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.