Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

Oral Mucositis Due to Radiation Clinical Trial

Official title:

The Effectiveness of Topical Oral Vitamin D Gel in Prevention of Radiation-induced Oral Mucositis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308161
• Other study ID #: IRB NO: 00010556-IORG 0008839
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2, 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Alexandria University
• Contact: Islam s Bakr, BDS
• Phone: 1067809063
• Email: dent.bakr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis

Description:

The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment.

All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

• Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.

Exclusion Criteria:

• Patients under Anticoagulants such as warfarin, heparin, or aspirin.

• Patients whose radiotherapy treatment planned dose is lower than 50 Gy.

• 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.

• Hyper-calcemic patients.

• Smokers.

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis Due to Radiation
• Stomatitis

Intervention

Drug:
• vitamin D oral gel
vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis
• Miconazole Topical Gel
topical anti fungal agent
• BBC oral spray
Topical anesthetics and anti-inflammatory agent
• Oracure gel
Topical analgesic gel

Other:
• Alkamisr sachets
Sodium bicarbonate mouthwash

Locations

Country	Name	City	State
Egypt	Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

References & Publications (50)

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in severity of oral mucositis at different time points along the study	Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session.	up to 3 and 6 weeks
Secondary	Pain and discomfort severity at different time points along the study: Numeric Rating Scale	Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session.	up to 3 and 6 weeks