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Trial Title:
Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis
NCT ID:
NCT06482034
Condition:
Radiation-Induced Mucositis
Conditions: Official terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Acetylcysteine
Zinc Sulfate
N-monoacetylcystine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
N-acetyl cysteine
Description:
N-acetyl cysteine sachets
Arm group label:
Group 1
Arm group label:
Group 3
Arm group label:
Group 4
Intervention type:
Drug
Intervention name:
Zinc sulfate
Description:
zinc sulfate capsules
Arm group label:
Group 3
Arm group label:
Group 4
Arm group label:
Group2
Intervention type:
Drug
Intervention name:
saline mouth wash
Description:
saline mouth wash
Arm group label:
Group 5
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mansoura university
Address:
City:
Mansoura
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nadia Aref, BDS,MS
Phone:
01002844332
Phone ext:
002
Email:
nadiaaref28@yahoo.com
Contact backup:
Last name:
Una El Shinnawi, BDS,MS,PhD
Phone:
01005061818
Phone ext:
002
Email:
una_shinnawi@yahoo.com
Start date:
June 28, 2023
Completion date:
November 2024
Lead sponsor:
Agency:
Mansoura University
Agency class:
Other
Source:
Mansoura University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06482034
