Efficacy of Aleo Vera Use in Prevention and Treatment of Chemotherapy-Induced Oral Mucositis in a Group of Egyptian Children with Acute Leukemia

December 26, 2024 updated by: Ain Shams University
evaluatation the efficacy of Aleovera in prevention and treatment of chemotherapy-induced oral mucositis in children suffering from acute leukemia in terms of appearance and severity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Patients suffering from Acute leukemia( Acute Lymphocytic Leukemia ).
  2. Patients scheduled for chemotherapy treatment.
  3. Patients who range from 3 to 13 years old.
  4. Patients with no history of any chemotherapy or radiotherapy. 5 -Both sexes Exclusion Criteria

1-Patients scheduled for radiotherapy treatment . 2-Existence of any signs or symptoms of oral mucositis. 3-Unwilling to participation in the study 4- Patients with any other systemic diseases or other neoplasms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alovera experminted arm
Other: Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis
Second arm : aleovera 3 times daily after brushing teeth
No Intervention: second group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of oral mucositis
Time Frame: 2 months

Assessment the efficacy of aleo vera gel on prevention of chemotherapy-induced oral mucositis through application the gel 3 times daily then patients were assessed daily in terms of appearance and severity of oral mucositis according WHO grading system.

The World Health Organization (WHO) mucositis scale is used to grade the severity of oral mucositis.

Grade 0: No mucositis Grade 1: Soreness/erythema only. Grade 2: Erythema, and ulcers. Able to tolerate solids. Grade 3: Unable to tolerate solids but able to tolerate liquids. Grade 4: Unable to tolerate solids or liquids. Oral alimentation is not possible.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Actual)

March 7, 2024

Study Completion (Actual)

March 7, 2024

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 26, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-EecIM 022203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

after analysis of my results, if be with value i will share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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