Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis
NCT ID: NCT04308161
Last Updated: 2020-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2019-11-02
2020-12-31
Brief Summary
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Detailed Description
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All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
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
Miconazole Topical Gel
topical anti fungal agent
BBC oral spray
Topical anesthetics and anti-inflammatory agent
Oracure gel
Topical analgesic gel
Alkamisr sachets
Sodium bicarbonate mouthwash
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
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
Alkamisr sachets
Sodium bicarbonate mouthwash
Interventions
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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
Alkamisr sachets
Sodium bicarbonate mouthwash
Eligibility Criteria
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Inclusion Criteria
* 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 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.
25 Years
ALL
Yes
Sponsors
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Hams Hamed Abdelrahman
OTHER
Responsible Party
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Hams Hamed Abdelrahman
Assistant lecturer
Principal Investigators
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Islam s Bakr, BDS
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
azza m zaki, Phd
Role: STUDY_DIRECTOR
Alexandria University
Riham m El-Moslemany, Phd
Role: STUDY_DIRECTOR
Alexandria University
Rasha o Elsaka, Phd
Role: STUDY_DIRECTOR
Alexandria University
Locations
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Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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References
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Other Identifiers
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IRB NO: 00010556-IORG 0008839
Identifier Type: -
Identifier Source: org_study_id
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