Back to resultsOmega-3 Hydrogel and Prevention of Oral Mucositis
Primary Purpose
Mucositis Oral
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
topical oral Omega-3 hydrogel
conventional preventive treatment
Sponsored by
About this trial
This is an interventional prevention trial for Mucositis Oral
Eligibility Criteria
Inclusion Criteria:
- Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
- Patients whose radiotherapy treatment planned dose is 50 Gy or above
- Males and females with an age not less than 18 years
- Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
Exclusion Criteria:
- Patients under Anticoagulants such as warfarin, heparin, or aspirin.
- Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Sites / Locations
- Faculty of Dentistry Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Topical oral Omega-3 hydrogel group
Conventional preventive treatment group
Arm Description
Patients will be given topical oral Omega-3 hydrogel
Patients will be given conventional preventive treatment
Outcomes
Primary Outcome Measures
Oral Mucositis Severity
Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05214495
Brief Title
Omega-3 Hydrogel and Prevention of Oral Mucositis
Official Title
Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Basma Morsy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical oral Omega-3 hydrogel group
Arm Type
Experimental
Arm Description
Patients will be given topical oral Omega-3 hydrogel
Arm Title
Conventional preventive treatment group
Arm Type
Active Comparator
Arm Description
Patients will be given conventional preventive treatment
Intervention Type
Drug
Intervention Name(s)
topical oral Omega-3 hydrogel
Intervention Description
Topical oral Omega-3 hydrogel prepared from fish oil
Intervention Type
Drug
Intervention Name(s)
conventional preventive treatment
Intervention Description
topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash.
Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)
Primary Outcome Measure Information:
Title
Oral Mucositis Severity
Description
Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
Patients whose radiotherapy treatment planned dose is 50 Gy or above
Males and females with an age not less than 18 years
Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
Exclusion Criteria:
Patients under Anticoagulants such as warfarin, heparin, or aspirin.
Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
Facility Information:
Facility Name
Faculty of Dentistry Alexandria University
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Hydrogel and Prevention of Oral Mucositis
We'll reach out to this number within 24 hrs