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Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

H

Hams Hamed Abdelrahman

Status and phase

Unknown
Phase 2

Conditions

Oral Mucositis Due to Radiation

Treatments

Drug: Oracure gel
Other: Alkamisr sachets
Drug: Miconazole Topical Gel
Drug: vitamin D oral gel
Drug: BBC oral spray

Study type

Interventional

Funder types

Other

Identifiers

NCT04308161
IRB NO: 00010556-IORG 0008839

Details and patient eligibility

About

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

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

25+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

vitamin D oral gel
Experimental group
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.
Treatment:
Drug: vitamin D oral gel
conventional therapy
Active Comparator group
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
Treatment:
Drug: Miconazole Topical Gel
Other: Alkamisr sachets
Drug: BBC oral spray
Drug: Oracure gel
combination therapy
Experimental group
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
Treatment:
Drug: Miconazole Topical Gel
Drug: vitamin D oral gel
Other: Alkamisr sachets
Drug: BBC oral spray
Drug: Oracure gel

Trial contacts and locations

1

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Central trial contact

Islam s Bakr, BDS

Data sourced from clinicaltrials.gov

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