Oral MucositisPhase 2NCT01400620
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
A Phase 2 study testing IZN-6N4 in people with Oral Mucositis, run by Izun Pharma Ltd at 10 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- IZN-6N4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2012to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of head and neck cancer
- planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy
- able to eat at least soft solids
- normal cardiac function
- able to perform oral rinse
Who cannot join
- Induction chemotherapy regimen
- life threatening allergic reaction to food and/or drugs
- history of any other primary malignancy diagnosed within the past 5 years
- prior radiation to the sites to be treated
- active infections of the oral cavity
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Israel6 sites
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Rabin Medical Center - Beilinson Campus
Petah Tikva
Sourasky Medical Center
Tel Aviv, 64239
Assuta Medical Center
Tel Aviv
Sheba Medical Center
Tel HaShomer, 52621
United States4 sites
UF Health Cancer Center
Gainesville, Florida, 32610
University of Miami-Sylvester CCC Clinical Research Services
Miami, Florida, 33136
Mount Sinai Beth Israel - Phillips Ambulatory Care Center
New York, New York, 10003
NYU Clinical Cancer Center
New York, New York, 10016
About this study
Official title: Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer
The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.
- Conditions
- Oral Mucositis
- Being tested
- IZN-6N4
- Keywords
- oral mucositis, chemoradiation, head and neck cancer
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IZN-6N4Drug
Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active oral rinse | Experimental | Oral rinse containing botanical extracts Receives: Drug: IZN-6N4 |
| Placebo rinse | Placebo comparator | Not described Receives: Drug: IZN-6N4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial
Measured: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.
Secondary outcomes (1)
Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure
Measured: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izun Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400620
- Sponsor's protocol ID
- IOM-HNC-201-IL
- Status last verified
- Mar 2018
- First submitted
- 20 Jul 2011
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01400620
- Acronym / sponsor ID
- IOM-HNC-201-IL
- Conditions
- Oral Mucositis
- Keywords
- oral mucositis, chemoradiation, head and neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Izun Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Jul 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 an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active oral rinse | Experimental | Drug: IZN-6N4Oral rinse containing botanical extracts |
| Placebo rinse | Placebo comparator | Drug: IZN-6N4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of head and neck cancer
- planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy
- able to eat at least soft solids
- normal cardiac function
- able to perform oral rinse
Key exclusion criteria (5 listed)
- Induction chemotherapy regimen
- life threatening allergic reaction to food and/or drugs
- history of any other primary malignancy diagnosed within the past 5 years
- prior radiation to the sites to be treated
- active infections of the oral cavity
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 |
|---|---|---|
| IZN-6N4Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks | Drug | Active oral rinse, Placebo rinse |
Primary outcome
Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
Time frame: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.
Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial
1 secondary outcome
Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure
Time frame: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two 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 13 Mar 2018.
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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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IZN-6N4 in people with Oral Mucositis, run by Izun Pharma Ltd at 10 sites in 2 countries.
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 5 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel, United States. 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?
Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups (time frame: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two 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 13 Mar 2018.