Oral Mucositis Due to RadiationPhase 2NCT04308161
Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis
A Phase 2 study testing vitamin D oral gel, Miconazole Topical Gel and BBC oral spray in people with Oral Mucositis Due to Radiation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis Due to Radiation
- What is being tested?
- vitamin D oral gel, Miconazole Topical Gel and BBC oral spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2019to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University
Alexandria
Islam s Bakr, BDS
About this study
Official title: 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
Read the 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.
- Conditions
- Oral Mucositis Due to Radiation
- Being tested
- vitamin D oral gel, Miconazole Topical Gel, BBC oral spray, Oracure gel, Alkamisr sachets
- Keywords
- vitamin D topical oral gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D oral gelDrug
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 GelDrug
topical anti fungal agent
BBC oral sprayDrug
Topical anesthetics and anti-inflammatory agent
Oracure gelDrug
Topical analgesic gel
Alkamisr sachetsOther
Sodium bicarbonate mouthwash
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Drug: vitamin D oral gel; Drug: Miconazole Topical Gel; Drug: BBC oral spray; Drug: Oracure gel; Other: Alkamisr sachets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 and 6 weeks
Secondary outcomes (1)
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.
Measured: up to 3 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start2 Nov 2019
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Oral Mucositis Due to RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Islam s Bakr, BDS, Principal investigator, Alexandria Universityazza m zaki, Phd, Study director, Alexandria UniversityRiham m El-Moslemany, Phd, Study director, Alexandria UniversityRasha o Elsaka, Phd, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308161
- Sponsor's protocol ID
- IRB NO: 00010556-IORG 0008839
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muanza TM, Cotrim AP, McAuliffe M, Sowers AL, Baum BJ, Cook JA, Feldchtein F, Amazeen P, Coleman CN, Mitchell JB. Evaluation of radiation-induced oral mucositis by optical coherence tomography. Clin Cancer Res. 2005 Jul 15;11(14):5121-7. doi: 10.1158/1078-0432.CCR-05-0403.
PubMed 16033826Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.
PubMed 28589080Rogulj AA, Brzak BL, Boras VV, Brailo V, Milenović M. Oral complications of head and neck irradiation. Libr Oncol. 2017;45(2-3):89-93.
Barkokebas A, Silva IH, de Andrade SC, Carvalho AA, Gueiros LA, Paiva SM, Leao JC. Impact of oral mucositis on oral-health-related quality of life of patients diagnosed with cancer. J Oral Pathol Med. 2015 Oct;44(9):746-51. doi: 10.1111/jop.12282. Epub 2014 Oct 25.
PubMed 25345344Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
PubMed 15782422Georgiou M, Patapatiou G, Domoxoudis S, Pistevou-Gompaki K, Papanikolaou A. Oral Mucositis: understanding the pathology and management. Hippokratia. 2012 Jul;16(3):215-6.
PubMed 23935285Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8.
PubMed 15605918Lee CS, Ryan EJ, Doherty GA. Gastro-intestinal toxicity of chemotherapeutics in colorectal cancer: the role of inflammation. World J Gastroenterol. 2014 Apr 14;20(14):3751-61. doi: 10.3748/wjg.v20.i14.3751.
PubMed 24744571Volpato LE, Silva TC, Oliveira TM, Sakai VT, Machado MA. Radiation therapy and chemotherapy-induced oral mucositis. Braz J Otorhinolaryngol. 2007 Jul-Aug;73(4):562-8. doi: 10.1016/s1808-8694(15)30110-5.
PubMed 17923929Elad S, Zadik Y. Chronic oral mucositis after radiotherapy to the head and neck: a new insight. Support Care Cancer. 2016 Nov;24(11):4825-30. doi: 10.1007/s00520-016-3337-5. Epub 2016 Jul 30.
PubMed 27475958Wuketich S, Hienz SA, Marosi C. Prevalence of clinically relevant oral mucositis in outpatients receiving myelosuppressive chemotherapy for solid tumors. Support Care Cancer. 2012 Jan;20(1):175-83. doi: 10.1007/s00520-011-1107-y. Epub 2011 Feb 18.
PubMed 21331484Peppone LJ, Mustian KM, Morrow GR, Dozier AM, Ossip DJ, Janelsins MC, Sprod LK, McIntosh S. The effect of cigarette smoking on cancer treatment-related side effects. Oncologist. 2011;16(12):1784-92. doi: 10.1634/theoncologist.2011-0169. Epub 2011 Dec 1.
PubMed 22135122Alongi F, Giaj-Levra N, Sciascia S, Fozza A, Fersino S, Fiorentino A, Mazzola R, Ricchetti F, Buglione M, Buonfrate D, Roccatello D, Ricardi U, Bisoffi Z. Radiotherapy in patients with HIV: current issues and review of the literature. Lancet Oncol. 2017 Jul;18(7):e379-e393. doi: 10.1016/S1470-2045(17)30440-0.
PubMed 28677574Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.
PubMed 25774860Herrstedt J. Prevention and management of mucositis in patients with cancer. Int J Antimicrob Agents. 2000 Oct;16(2):161-3. doi: 10.1016/s0924-8579(00)00232-6.
PubMed 11053801
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Topical Oral Vitamin D Gel in Prevention of Radiation-induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT04308161
- Acronym / sponsor ID
- IRB NO: 00010556-IORG 0008839
- Conditions
- Oral Mucositis Due to Radiation
- Keywords
- vitamin D topical oral gel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin D oral gel | Experimental | Drug: vitamin D oral gelTopical 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 | Active comparator | Drug: Miconazole Topical Gel, Drug: BBC oral spray, Drug: Oracure gel, Other: Alkamisr sachetsConventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks |
| combination therapy | Experimental | Drug: vitamin D oral gel, Drug: Miconazole Topical Gel, Drug: BBC oral spray, Drug: Oracure gel, Other: Alkamisr sachetsTopical 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 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D oral gelvitamin 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 | combination therapy, vitamin D oral gel |
| Miconazole Topical Geltopical anti fungal agent | Drug | combination therapy, conventional therapy |
| BBC oral sprayTopical anesthetics and anti-inflammatory agent | Drug | combination therapy, conventional therapy |
| Oracure gelTopical analgesic gel | Drug | combination therapy, conventional therapy |
| Alkamisr sachetsSodium bicarbonate mouthwash | Other | combination therapy, conventional therapy |
Primary outcome
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.
1 secondary outcome
Pain and discomfort severity at different time points along the study: Numeric Rating Scale
Time frame: up to 3 and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 16033826Muanza TM, Cotrim AP, McAuliffe M, Sowers AL, Baum BJ, Cook JA, Feldchtein F, Amazeen P, Coleman CN, Mitchell JB. Evaluation of radiation-induced oral mucositis by optical coherence tomography. Clin Cancer Res. 2005 Jul 15;11(14):5121-7. doi: 10.1158/1078-0432.CCR-05-0403.
- Background: PubMed 28589080Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.
- BackgroundRogulj AA, Brzak BL, Boras VV, Brailo V, Milenović M. Oral complications of head and neck irradiation. Libr Oncol. 2017;45(2-3):89-93.
- Background: PubMed 25345344Barkokebas A, Silva IH, de Andrade SC, Carvalho AA, Gueiros LA, Paiva SM, Leao JC. Impact of oral mucositis on oral-health-related quality of life of patients diagnosed with cancer. J Oral Pathol Med. 2015 Oct;44(9):746-51. doi: 10.1111/jop.12282. Epub 2014 Oct 25.
- Background: PubMed 15782422Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
- Background: PubMed 23935285Georgiou M, Patapatiou G, Domoxoudis S, Pistevou-Gompaki K, Papanikolaou A. Oral Mucositis: understanding the pathology and management. Hippokratia. 2012 Jul;16(3):215-6.
- Background: PubMed 15605918Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8.
- Background: PubMed 24744571Lee CS, Ryan EJ, Doherty GA. Gastro-intestinal toxicity of chemotherapeutics in colorectal cancer: the role of inflammation. World J Gastroenterol. 2014 Apr 14;20(14):3751-61. doi: 10.3748/wjg.v20.i14.3751.
- Background: PubMed 17923929Volpato LE, Silva TC, Oliveira TM, Sakai VT, Machado MA. Radiation therapy and chemotherapy-induced oral mucositis. Braz J Otorhinolaryngol. 2007 Jul-Aug;73(4):562-8. doi: 10.1016/s1808-8694(15)30110-5.
- Background: PubMed 27475958Elad S, Zadik Y. Chronic oral mucositis after radiotherapy to the head and neck: a new insight. Support Care Cancer. 2016 Nov;24(11):4825-30. doi: 10.1007/s00520-016-3337-5. Epub 2016 Jul 30.
- Background: PubMed 21331484Wuketich S, Hienz SA, Marosi C. Prevalence of clinically relevant oral mucositis in outpatients receiving myelosuppressive chemotherapy for solid tumors. Support Care Cancer. 2012 Jan;20(1):175-83. doi: 10.1007/s00520-011-1107-y. Epub 2011 Feb 18.
- Background: PubMed 22135122Peppone LJ, Mustian KM, Morrow GR, Dozier AM, Ossip DJ, Janelsins MC, Sprod LK, McIntosh S. The effect of cigarette smoking on cancer treatment-related side effects. Oncologist. 2011;16(12):1784-92. doi: 10.1634/theoncologist.2011-0169. Epub 2011 Dec 1.
- Individual participant dataSharing planned: No
Related trials for Oral Mucositis Due to Radiation
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
Active, not recruitingObservational study
Multicentre Real-life Data Collection Study With CareMin650™ in the Prevention and Treatment of Oral Mucositis and Radio- and/or Chemo-induced Dermatitis
Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Not yet recruitingPhase 2
Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis
Oral Mucositis (Ulcerative) Due to Radiation
Not yet recruiting
A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer
Oral Mucositis Due to Radiation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Islam s Bakr, BDS principal investigator
Alexandria University
azza m zaki, Phd study director
Alexandria University
Riham m El-Moslemany, Phd study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vitamin D oral gel, Miconazole Topical Gel and BBC oral spray in people with Oral Mucositis Due to Radiation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Islam s Bakr, BDS (1067809063 ext. 0020, dent.bakr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in severity of oral mucositis at different time points along the study (time frame: up to 3 and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308161, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.