NCT06757270

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

December 17, 2024

Last Update Submit

December 26, 2024

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

  • Prevention of oral mucositis

    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

Study Arms (2)

Alovera experminted arm

EXPERIMENTAL
Other: Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral Mucositis

second group

NO INTERVENTION

Interventions

Second arm: Using aleovera for Prevention and Treatment of Chemotherapy-Induced Oral MucositisOTHER

Second arm : aleovera 3 times daily after brushing teeth

Alovera experminted arm

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients suffering from Acute leukemia( Acute Lymphocytic Leukemia ).
  • Patients scheduled for chemotherapy treatment.
  • Patients who range from 3 to 13 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

January 3, 2025

Study Start

March 7, 2023

Primary Completion

March 7, 2024

Study Completion

March 7, 2024

Last Updated

January 3, 2025

Record last verified: 2024-03

Locations

EG(1)