Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

March 12, 2020 updated by: Hams Hamed Abdelrahman

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
        • Principal Investigator:
          • Islam s Bakr, BDS

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

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: vitamin D oral gel

Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks.

Topical oral Vitamin D gel is prepared with the aid of pharmaceutics department, faculty of pharmacy, Alexandria University. It is prepared by using Cholecalciferol 2ml ampoule (200.000 I.U.) within topical oral gel formulation.
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
Active Comparator: conventional therapy

Conventional therapy (symptomatic treatment) which included:

  • Miconaz oral gel
  • BBC oral spray
  • Oracure gel
  • Alkamisr sachets

Dose: Three times a day for six weeks
Drug: Miconazole Topical Gel
topical anti fungal agent
Drug: BBC oral spray
Topical anesthetics and anti-inflammatory agent
Drug: Oracure gel
Topical analgesic gel
Other: Alkamisr sachets
Sodium bicarbonate mouthwash
Experimental: combination therapy

Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment

Symptomatic treatment which included:

  • Miconaz oral gel
  • BBC oral spray
  • Oracure gel
  • Alkamisr sachets

Symptomatic treatment dose: Three times a day for six weeks
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
Drug: Miconazole Topical Gel
topical anti fungal agent
Drug: BBC oral spray
Topical anesthetics and anti-inflammatory agent
Drug: Oracure gel
Topical analgesic gel
Other: Alkamisr sachets
Sodium bicarbonate mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in severity of oral mucositis at different time points along the study
Time Frame: up to 3 and 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and discomfort severity at different time points along the study: Numeric Rating Scale
Time Frame: up to 3 and 6 weeks
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

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

Investigators

  • Principal Investigator: Islam s Bakr, BDS, Alexandria University
  • Study Director: azza m zaki, Phd, Alexandria University
  • Study Director: Riham m El-Moslemany, Phd, Alexandria University
  • Study Director: Rasha o Elsaka, Phd, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 2, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB NO: 00010556-IORG 0008839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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