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Omega-3 Hydrogel and Prevention of Oral Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05214495
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Basma Morsy, Alexandria University

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.

Condition or disease Intervention/treatment Phase
Mucositis Oral Drug: topical oral Omega-3 hydrogel Drug: conventional preventive treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 9, 2022
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Topical oral Omega-3 hydrogel group
Patients will be given topical oral Omega-3 hydrogel
Drug: topical oral Omega-3 hydrogel
Topical oral Omega-3 hydrogel prepared from fish oil

Active Comparator: Conventional preventive treatment group
Patients will be given conventional preventive treatment
Drug: conventional preventive treatment

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 Measures :
  1. Oral Mucositis Severity [ Time Frame: up to 6 weeks ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
  2. Patients whose radiotherapy treatment planned dose is 50 Gy or above
  3. Males and females with an age not less than 18 years
  4. Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.

Exclusion Criteria:

  1. Patients under Anticoagulants such as warfarin, heparin, or aspirin.
  2. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
  3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214495


Contacts
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Contact: Basma Morsy 01018222678 ext +2 Basma.Mohamed.dent@alexu.edu.eg

Locations
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Egypt
Faculty of Dentistry Alexandria University Recruiting
Alexandria, Egypt
Contact: Basma Morsy    01018222678 ext +2    Basma.Mohamed.dent@alexu.edu.eg   
Sponsors and Collaborators
Basma Morsy
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Responsible Party: Basma Morsy, Principal Investigator, Alexandria University
ClinicalTrials.gov Identifier: NCT05214495    
Other Study ID Numbers: 0290-09/2021
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases