Radiation-induced Mucositis of Oral Mucous MembranesPhase 2NCT01375088
Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
A Phase 2 study testing propolis in people with Radiation-induced Mucositis of Oral Mucous Membranes, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Radiation-induced Mucositis of Oral Mucous Membranes
- What is being tested?
- propolis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Oct 2010to May 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- need of radiotherapy
- at least half of the mouth in the field of radiation
- dose 50 -70 Gy
- head \& neck malignancy
Who cannot join
- systemic disease
- FBS > 150 WBC > 3000
- history of radiotherapy
- need of chemotherapy
- systemic disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Medical Science
Mashhad, Razavi Khorasan Province
About this study
Official title: Phase I Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.
Read the detailed description
Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.
- Being tested
- propolis
- Keywords
- propolis, mucositis, radiotherapy, cancer
- Medical subject headings
- Mucositis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propolisDrug
15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow
| Study group | Role | What they receive |
|---|---|---|
| placebo mouth wash | Placebo comparator | 10 patients swish \& swallow 15 ml placebo mouth wash for at least 5 min from the first session of radiotherapy until the last session Receives: Drug: propolis |
| propolis | Active comparator | 10 patients swish \& swallow 15 ml propolis mouth wash for at least 5 min from the first session of radiotherapy until the last session Receives: Drug: propolis |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCI.CTC Scale
we use NCI-CTC scale for patients in 2 groups to assess effect of propolis mouth wash on prevention and treatment of mucositis in patients under radiotherapy.We measured signs(size and sypmtoms) of mucositis by NCI-CTC scale and also we assessed the onset of the mucositis to describe the prevention efficacy of propolis.
Measured: 9 month
Secondary outcomes (1)
hyposalivation scale
we use a scale for patients in 2 groups to assess effect of propolis maouth wash on subjective xerostomy and signs of candidiasis in patiants under radiotherapy
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Mucositis of Oral Mucous MembranesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATESSA PAKFETRAT, Mashhad University of Medical Sciences
- Investigators
- arghavan tonkaboni, resident, Principal investigator, oral medicine dep, dental school, mashhad university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375088
- Sponsor's protocol ID
- 339888
- Status last verified
- Nov 2012
- First submitted
- 1 Jun 2011
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT01375088
- Acronym / sponsor ID
- 339888
- Keywords
- propolis, mucositis, radiotherapy, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Jun 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.
The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.
Detailed description
Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo mouth wash | Placebo comparator | Drug: propolis10 patients swish \& swallow 15 ml placebo mouth wash for at least 5 min from the first session of radiotherapy until the last session |
| propolis | Active comparator | Drug: propolis10 patients swish \& swallow 15 ml propolis mouth wash for at least 5 min from the first session of radiotherapy until the last session |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- need of radiotherapy
- at least half of the mouth in the field of radiation
- dose 50 -70 Gy
- head \& neck malignancy
Key exclusion criteria (5 listed)
- systemic disease
- FBS > 150 WBC > 3000
- history of radiotherapy
- need of chemotherapy
- systemic disease
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 |
|---|---|---|
| propolis15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow | Drug | placebo mouth wash, propolis |
Primary outcome
NCI.CTC Scale
Time frame: 9 month
we use NCI-CTC scale for patients in 2 groups to assess effect of propolis mouth wash on prevention and treatment of mucositis in patients under radiotherapy.We measured signs(size and sypmtoms) of mucositis by NCI-CTC scale and also we assessed the onset of the mucositis to describe the prevention efficacy of propolis.
1 secondary outcome
hyposalivation scale
Time frame: 9 month
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 22 Nov 2012.
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.
arghavan tonkaboni, resident principal investigator
oral medicine dep, dental school, mashhad university of medical science
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 propolis in people with Radiation-induced Mucositis of Oral Mucous Membranes, run by Mashhad 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 5 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 22 Nov 2012. 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 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?
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?
NCI.CTC Scale (time frame: 9 month). 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 22 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.