Chemotherapy Induced Oral MucositisPhase 1/2NCT01732393
Effect of Quercetin in Prevention and Treatment of Oral Mucositis
A Phase 1/2 study testing oral quercetin capsules in people with Chemotherapy Induced Oral Mucositis, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Chemotherapy Induced Oral Mucositis
- What is being tested?
- oral quercetin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Jan 2012
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient under chemotherapy
- for a hematologic malignancy
- the hematologist permits the trial on the patient
- agreement of patient for participating in the trial
Who cannot join
- presence pf ANY oral lesion at the beginning of the trial
- loss of follow up
- use of digoxin and cyclosporine
- patient death
Trial locations and contacts
1 site in 1 country.
Iran1 site
Oral Medicine Department of Mashhad dental School
Mashhad, Razavi Khorasan Province, 91735-498
About this study
Official title: Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias
The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.
- Conditions
- Chemotherapy Induced Oral Mucositis
- Being tested
- oral quercetin capsules, Placebo
- Keywords
- Quercetin, Chemotherapy, Mucositis, Hematologic Malignancies
- Medical subject headings
- Mucositis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral quercetin capsulesDrug
10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| oral quercetin capsules | Active comparator | Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks Receives: Drug: oral quercetin capsules |
| oral placebo capsules | Placebo comparator | Patients in the placebo group received two placebo capsules containing lactose . Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower grade of mucositis
grade of mucositis due to WHO criteria
Measured: 3 weeks
Secondary outcomes (1)
duration of mucositis
duration of mucositis due to Who criteria
Measured: 3 weeks of study tiem span and after trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Oral 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pegah Mosannen Mozafari, Mashhad University of Medical Sciences
- Investigators
- Pegah Mosannen Mozafari, assistant professor, Study director, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732393
- Sponsor's protocol ID
- 89470
- Status last verified
- Dec 2012
- First submitted
- 19 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias
- ClinicalTrials.gov ID
- NCT01732393
- Acronym / sponsor ID
- 89470
- Conditions
- Chemotherapy Induced Oral Mucositis
- Keywords
- Quercetin, Chemotherapy, Mucositis, Hematologic Malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Nov 2012 (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 study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral quercetin capsules | Active comparator | Drug: oral quercetin capsulesPatients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks |
| oral placebo capsules | Placebo comparator | Drug: PlaceboPatients in the placebo group received two placebo capsules containing lactose . |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patient under chemotherapy
- for a hematologic malignancy
- the hematologist permits the trial on the patient
- agreement of patient for participating in the trial
Key exclusion criteria (4 listed)
- presence pf ANY oral lesion at the beginning of the trial
- loss of follow up
- use of digoxin and cyclosporine
- patient death
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 |
|---|---|---|
| oral quercetin capsules10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis. | Drug | oral quercetin capsules |
| Placebo | Drug | oral placebo capsules |
Primary outcome
lower grade of mucositis
Time frame: 3 weeks
grade of mucositis due to WHO criteria
1 secondary outcome
duration of mucositis
Time frame: 3 weeks of study tiem span and after trial
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 5 Dec 2012.
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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.
Pegah Mosannen Mozafari, assistant professor study director
Mashhad University of Medical Sciences
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 oral quercetin capsules in people with Chemotherapy Induced Oral Mucositis, 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 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: finished, as of the sponsor's last update on 5 Dec 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 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?
lower grade of mucositis (time frame: 3 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 5 Dec 2012.