Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
Study NCT ID:
NCT06879366
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2025-03-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Prevention of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
Sponsor:
October 6 University
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Treatment of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2025-03
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:
Background and Rationale Oral mucositis (OM) is one of the most debilitating toxic side effects of radiotherapy and chemotherapy. \]Radiation-induced OM occurs due to the generation of free radicals, which induce mitochondrial dysfunction resulting in increased oxidative stress, DNA damage and cell apoptosis. Epidermal growth factor (EGF) levels were decreased in patients with severe OM, and patients with lower levels of EGF prior to therapy may indicate increased risk of mucosal damage during RT
Objectives:
The purpose of this study is for Evaluation of the efficacy of aloe-vera gel versus standard treatment as a new option in the treatment of radiation-induced oral mucositis
Study population \& Sample size :
40 patient proven to have Head and neck cancer , requiring radiotherapy.
Study Design:
RCT. The patients are randomized and divided into 2 groups , group A will use alovera gel , Group B will use benzylamide gel, EGF will be measured in saliva before and after 4 weeks treatment Methods Patient's visits will be at baseline, 2 weeks and 4 weeks. At follow up visits patients will be instructed to bring back the consumed container to check that they had totally consumed their previous supply before giving them the new one. Saliva collection to measure EGF by ELIZA
Objectives:
The purpose of this study is for Evaluation of the efficacy of aloe-vera gel versus standard treatment as a new option in the treatment of radiation-induced oral mucositis
Study population \& Sample size :
40 patient proven to have Head and neck cancer , requiring radiotherapy.
Study Design:
RCT. The patients are randomized and divided into 2 groups , group A will use alovera gel , Group B will use benzylamide gel, EGF will be measured in saliva before and after 4 weeks treatment Methods Patient's visits will be at baseline, 2 weeks and 4 weeks. At follow up visits patients will be instructed to bring back the consumed container to check that they had totally consumed their previous supply before giving them the new one. Saliva collection to measure EGF by ELIZA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: