Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482034
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-03
Brief Title:
Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None