Oral Mucositis (Ulcerative) Due to RadiationPhase 2NCT01318889
Dexpanthenol Mouthwash to Treat Oral Mucositis
A Phase 2 study testing Dexpanthenol in people with Oral Mucositis (Ulcerative) Due to Radiation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Mucositis (Ulcerative) Due to Radiation
- What is being tested?
- Dexpanthenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Sep 2010to Sep 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- without any systemic disease
- estimated survival of at least 6 months
- without any mental disorders
- grade 1 to 3 WHO mucositis
Who cannot join
- development of grade 4 WHO mucositis
- Brachytherapy
- allergy to the drug
- dissatisfaction of the patient
Trial locations and contacts
1 site in 1 country.
Jamileh beigom Taheri, professor contact
Iran1 site, 1 recruiting
- Recruiting
ShaheedBeheshti medical university
Tehran
Fahimeh Anbari, postgraduate student
Jamileh beigom Taheri, professor
About this study
Official title: Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis
Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. The stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. The investigators suppose that dexpanthenol mouth wash may improve oral mucositis.
Read the detailed description
Patients will be given a bottle of 5% Dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. At the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.By the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.
- Being tested
- Dexpanthenol
- Keywords
- Dexpanthenol, Radiotherapy, chemotherapy, Mucositis
- Medical subject headings
- Stomatitis, Ulcer, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexpanthenolDrug
Also called Physiologic serum
5% dexpanthenol Mouth wash , three times a day, 10 cc each time
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Experimental | mouth wash of normal saline ,three times a day, 10 cc each time Receives: Drug: Dexpanthenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of intensity of mucositis
measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort
Measured: first week (week one)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis (Ulcerative) 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Fahimeh Anbari, resident, Principal investigator, dental faculty of shaheed Beheshti medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318889
- Sponsor's protocol ID
- BMU1360
- Status last verified
- Jun 2010
- First submitted
- 8 Mar 2011
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT01318889
- Acronym / sponsor ID
- BMU1360
- Keywords
- Dexpanthenol, Radiotherapy, chemotherapy, Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 21 Mar 2011 (estimated)
- 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.
Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. The stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. The investigators suppose that dexpanthenol mouth wash may improve oral mucositis.
Detailed description
Patients will be given a bottle of 5% Dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. At the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.By the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal saline | Experimental | Drug: Dexpanthenolmouth wash of normal saline ,three times a day, 10 cc each time |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- without any systemic disease
- estimated survival of at least 6 months
- without any mental disorders
- grade 1 to 3 WHO mucositis
Key exclusion criteria (4 listed)
- development of grade 4 WHO mucositis
- Brachytherapy
- allergy to the drug
- dissatisfaction of the patient
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 |
|---|---|---|
| DexpanthenolAlso: Physiologic serum5% dexpanthenol Mouth wash , three times a day, 10 cc each time | Drug | normal saline |
Primary outcome
reduction of intensity of mucositis
Time frame: first week (week one)
measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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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.
Jamileh beigom Taheri, professor contact
Fahimeh Anbari, resident principal investigator
dental faculty of shaheed Beheshti medical 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 Dexpanthenol in people with Oral Mucositis (Ulcerative) Due to Radiation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 4 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 6 Jul 2011. 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 Iran. 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 Fahimeh Anbari, resident (+98 9197263620, fahimeh.anbari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of intensity of mucositis (time frame: first week (week one)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2011.