MucositisPhase 1/2NCT02075749
Comparing Triamcinolone Acetonide Mucoadhesive Films With Licorice Mucoadhesive Films
A Phase 1/2 study testing Triamcinolone Acetonide and licorice mucoadhesive films in people with Mucositis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Abstract: Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief, correction of nutritional status and improving the performance status. However, lack of standardization is the major obstacle for any scientific evaluation of any CAM trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucositis
- What is being tested?
- Triamcinolone Acetonide and licorice mucoadhesive films
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- May 2013to Feb 2014
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years of age
- men and nonpregnant women
- women of childbearing age who were non-pregnant by pregnancy test and and using medically prescribed contraceptive
- no previous radiation therapy applied in the head and neck
- medically fit for a course of radical radiotherapy
- an ability to remain in the study for its entire duration
Who cannot join
- pregnant women
- women of childbearing potential in whom medically prescribed birth control was not used
- concurrent chemotherapy
- history of heavy alcohol or drug abuse judged to be important by the investigator - concomitant therapy with an investigational drug, or cancer chemo therapeutics or immunosuppressive medications
- sensitivity or intolerance to triamcinolone or licorice, lactose or similar formulations
- inability to provide informed consent
Show all 9Show fewer
- actively bleeding gastric ulcer, severe esophageal reflux
- major surgery, trauma or burns in the preceding 4 weeks
- clinically significant hepatic, neurologic, endocrine, or other systemic disease-making implementation of the protocol or results difficult.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial
Abstract:
Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief, correction of nutritional status and improving the performance status. However, lack of standardization is the major obstacle for any scientific evaluation of any CAM trial. Mucositis is a major complication of irradiation in head and neck (H\&N) tumors, the addition of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films on oral mucositis in terms of pain control and/or ulcer treatment.
Methods and Materials: the study was a double-blind, randomized prospective trial of two types of mucoadhesive films in the management of oral mucositis occurred during head and neck cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films, an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.
- Conditions
- Mucositis
- Being tested
- Triamcinolone Acetonide, licorice mucoadhesive films
- Keywords
- irradiation, mucositis, triamcinolone acetonide, licorice, mucoadhesive film
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called made in Germany (Merck)
licorice mucoadhesive filmsDrug
Also called AFTOGEL Patch
30 patients received licorice mucoadhesive films
| Study group | Role | What they receive |
|---|---|---|
| triamcinolone acetonide mucoadhesive | Active comparator | 30 patients received triamcinolone acetonide mucoadhesive films Receives: Drug: Triamcinolone Acetonide |
| Licorice | Experimental | 30 patients received licorice mucoadhesive films Receives: Drug: licorice mucoadhesive films |
| Mucoadhesive film | Placebo comparator | 30 patients received mucoadhesive films without any drug ingredients |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
at the end of each consecutive week the pain score was recorded.
Measured: 4 weeks
Secondary outcomes (1)
mucositis grade
the grading of mucositis was assessed and recorded at the end of each week.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075749
- Sponsor's protocol ID
- 393009
- Status last verified
- Jul 2014
- First submitted
- 26 Feb 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Triamcinolone Acetonide Mucoadhesive Film With Liquorice Mucoadhesive Film On Radiotherapy-Induced Oral Mucositis: A Randomized Double-Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02075749
- Acronym / sponsor ID
- 393009
- Conditions
- Mucositis
- Keywords
- irradiation, mucositis, triamcinolone acetonide, licorice, mucoadhesive film
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Mar 2014 (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.
Abstract:
Background: Complementary and alternative medicine (CAM) had proven efficacy in pain relief, correction of nutritional status and improving the performance status. However, lack of standardization is the major obstacle for any scientific evaluation of any CAM trial. Mucositis is a major complication of irradiation in head and neck (H\&N) tumors, the addition of chemotherapy to irradiation may enhance this dose limiting problem. Licorice is a strong demulcent that had been effectively used in treatment of peptic ulcer. The main purpose of this study was to compare the therapeutic safety and efficacy of T. and L. mucoadhesive films on oral mucositis in terms of pain control and/or ulcer treatment.
Methods and Materials: the study was a double-blind, randomized prospective trial of two types of mucoadhesive films in the management of oral mucositis occurred during head and neck cancer ( HNC ) radiotherapy. oral mucositis was assessed using a quantitative scale (WHO scales) and symptoms were assessed using visual analogue scales (VAS). 60 patients were enrolled in the study; there were 30 patients in the Triamcinolone (T) and 30 in the Licorice (L) group. In the T- group, patients received triamcinolone acetonide mucoadhesive films containing 1mg of the drug and patients in the L- group received licorice mucoadhesive films, an herbal agent. Data were collected at baseline, then twice a week for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| triamcinolone acetonide mucoadhesive | Active comparator | Drug: Triamcinolone Acetonide30 patients received triamcinolone acetonide mucoadhesive films |
| Licorice | Experimental | Drug: licorice mucoadhesive films30 patients received licorice mucoadhesive films |
| Mucoadhesive film | Placebo comparator | –30 patients received mucoadhesive films without any drug ingredients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- over 18 years of age
- men and nonpregnant women
- women of childbearing age who were non-pregnant by pregnancy test and and using medically prescribed contraceptive
- no previous radiation therapy applied in the head and neck
- medically fit for a course of radical radiotherapy
Key exclusion criteria (9 listed)
- pregnant women
- women of childbearing potential in whom medically prescribed birth control was not used
- concurrent chemotherapy
- history of heavy alcohol or drug abuse judged to be important by the investigator - concomitant therapy with an investigational drug, or cancer chemo therapeutics or immunosuppressive medications
- sensitivity or intolerance to triamcinolone or licorice, lactose or similar formulations
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: made in Germany (Merck) | Drug | triamcinolone acetonide mucoadhesive |
| licorice mucoadhesive filmsAlso: AFTOGEL Patch30 patients received licorice mucoadhesive films | Drug | Licorice |
Primary outcome
pain score
Time frame: 4 weeks
at the end of each consecutive week the pain score was recorded.
1 secondary outcome
mucositis grade
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Triamcinolone Acetonide and licorice mucoadhesive films in people with Mucositis, run by Isfahan 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 10 Jul 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 4 weeks). 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 10 Jul 2014.