NCT06879366CompletedPhase 4
Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Prevention of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Treatment of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 11 Mar 2025
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- October 6 University
- Diseases
- Head and neck cancer
- NCT number
- NCT06879366
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 40
- From 1 Jun 2023 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients under the age of 18 ,patients receiving any previous treatment for oral mucositis during the last 2 weeks, allergy to aloe-vera, patients with chronic liver disease, infectious diseases (HIV, HBV,HCV,….), immune system dysfunction, haematological diseases and pregnancy or breast-feeding
Who the study is looking for
- The study will include patients who are diagnosed with radiation-induced oral mucositis with any of its grades as scored by the world health organization (WHO) oral mucositis grading scale.
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cairo University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.