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Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

Primary Purpose

Oral Mucositis Due to Radiation

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
vitamin D oral gel
Miconazole Topical Gel
BBC oral spray
Oracure gel
Alkamisr sachets
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis Due to Radiation focused on measuring vitamin D topical oral gel

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

vitamin D oral gel

conventional therapy

combination therapy

Arm Description

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.

Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Dose: Three times a day for six weeks

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 12, 2020
Last Updated
March 12, 2020
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04308161
Brief Title
Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis
Official Title
The Effectiveness of Topical Oral Vitamin D Gel in Prevention of Radiation-induced Oral Mucositis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis Due to Radiation
Keywords
vitamin D topical oral gel

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin D oral gel
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Dose: Three times a day for six weeks
Arm Title
combination therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
vitamin D oral gel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Miconazole Topical Gel
Intervention Description
topical anti fungal agent
Intervention Type
Drug
Intervention Name(s)
BBC oral spray
Intervention Description
Topical anesthetics and anti-inflammatory agent
Intervention Type
Drug
Intervention Name(s)
Oracure gel
Intervention Description
Topical analgesic gel
Intervention Type
Other
Intervention Name(s)
Alkamisr sachets
Intervention Description
Sodium bicarbonate mouthwash
Primary Outcome Measure Information:
Title
Changes in severity of oral mucositis at different time points along the study
Description
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.
Time Frame
up to 3 and 6 weeks
Secondary Outcome Measure Information:
Title
Pain and discomfort severity at different time points along the study: Numeric Rating Scale
Description
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.
Time Frame
up to 3 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Islam s Bakr, BDS
Phone
1067809063
Ext
0020
Email
dent.bakr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Islam s Bakr, BDS
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
azza m zaki, Phd
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Riham m El-Moslemany, Phd
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasha o Elsaka, Phd
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Islam s Bakr, BDS

12. IPD Sharing Statement

Plan to Share IPD
No
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Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

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