Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis

NCT04308161 | Unknown Phase 2

• 1 other identifier: IRB NO: 00010556-IORG 0008839
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Mucositis Due to Radiation

Keywords

vitamin D topical oral gel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain and discomfort severity at different time points along the study: Numeric Rating Scale

  up to 3 and 6 weeks

Study Arms (3)

vitamin D oral gel

EXPERIMENTAL

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

conventional therapy

ACTIVE COMPARATOR

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; Drug: BBC oral spray; Drug: Oracure gel; Other: Alkamisr sachets

combination therapy

EXPERIMENTAL

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

Interventions

vitamin D oral gel DRUG

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

combination therapy; vitamin D oral gel

Miconazole Topical Gel DRUG

topical anti fungal agent

combination therapy; conventional therapy

BBC oral spray DRUG

Topical anesthetics and anti-inflammatory agent

combination therapy; conventional therapy

Oracure gel DRUG

Topical analgesic gel

combination therapy; conventional therapy

Alkamisr sachets OTHER

Sodium bicarbonate mouthwash

combination therapy; conventional therapy

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (50)

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Study Officials

• Islam s Bakr, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• azza m zaki, Phd

  Alexandria University

  STUDY DIRECTOR

• Riham m El-Moslemany, Phd

  Alexandria University

  STUDY DIRECTOR

• Rasha o Elsaka, Phd

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Islam s Bakr, BDS

CONTACT

1067809063; dent.bakr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 13, 2020
• Study Start: November 2, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)