MucositisPhase 1NCT01092975
Safety of Phenylephrine for Oral Mucositis Prevention
A Phase 1 study testing phenylephrine solution in people with Mucositis and Stomatitis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mucositis, Stomatitis
- What is being tested?
- phenylephrine solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2011
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes
- normal ECG
- normal blood pressure
Who cannot join
- untreated cardiac disease
- connective tissue disorders
- open sores, wound, ulcerations to oral cavity
- allergy to phenylephrine
- know untreated hypertensin
- abnormal ECG in past 6 months
- taking prescription monoamine oxidase inhibitor (MAOI)
- are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes
The purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes.
- Conditions
- Mucositis, Stomatitis
- Being tested
- phenylephrine solution
- Keywords
- radiotherapy
- Medical subject headings
- Mucositis, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenylephrine solutionDrug
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
| Study group | Role | What they receive |
|---|---|---|
| 1.25 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
| 2.5 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
| 5.0 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
| 10.0 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
| 20.0 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
| 40.0 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
| 60.0 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
| 80.0 mg phenylephrine | Experimental | Not described Receives: Drug: phenylephrine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.
Measured: 24 months
Secondary outcomes (1)
Efficacy: the the mucositis severity area-under-the-curve (AUC) where the severity of oral mucositis on each treatment day will be scored, summed, and plotted graphically.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionApr 2011
Why it stopped: formulation/dose changes; planned changes to safety monitoring/reporting
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.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James F Cleary, MBBS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092975
- Sponsor's protocol ID
- H-2009-0077
- Other IDs
- NCI-2011-00742, CO09901
- Status last verified
- Dec 2020
- First submitted
- 23 Mar 2010
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes
- ClinicalTrials.gov ID
- NCT01092975
- Acronym / sponsor ID
- H-2009-0077
- Conditions
- Mucositis, Stomatitis
- Keywords
- radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: formulation/dose changes; planned changes to safety monitoring/reporting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Mar 2010 (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 if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1.25 mg phenylephrine | Experimental | Drug: phenylephrine solution |
| 2.5 mg phenylephrine | Experimental | Drug: phenylephrine solution |
| 5.0 mg phenylephrine | Experimental | Drug: phenylephrine solution |
| 10.0 mg phenylephrine | Experimental | Drug: phenylephrine solution |
| 20.0 mg phenylephrine | Experimental | Drug: phenylephrine solution |
| 40.0 mg phenylephrine | Experimental | Drug: phenylephrine solution |
| 60.0 mg phenylephrine | Experimental | Drug: phenylephrine solution |
| 80.0 mg phenylephrine | Experimental | Drug: phenylephrine solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes
- normal ECG
- normal blood pressure
Key exclusion criteria (8 listed)
- untreated cardiac disease
- connective tissue disorders
- open sores, wound, ulcerations to oral cavity
- allergy to phenylephrine
- know untreated hypertensin
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 |
|---|---|---|
| phenylephrine solutionSubjects will receive up to 40 dose of topical phenylephrine at the specified dose level. | Drug | 1.25 mg phenylephrine, 10.0 mg phenylephrine, 2.5 mg phenylephrine, 20.0 mg phenylephrine, 40.0 mg phenylephrine, 5.0 mg phenylephrine, 60.0 mg phenylephrine, 80.0 mg phenylephrine |
Primary outcome
Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.
Time frame: 24 months
1 secondary outcome
Efficacy: the the mucositis severity area-under-the-curve (AUC) where the severity of oral mucositis on each treatment day will be scored, summed, and plotted graphically.
Time frame: 24 months
Results and safety
The study was stopped early (reason given: formulation/dose changes; planned changes to safety monitoring/reporting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
James F Cleary, MBBS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing phenylephrine solution in people with Mucositis and Stomatitis, run by University of Wisconsin, Madison at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Dec 2020. 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 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. 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 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.
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 was stopped early (reason given: formulation/dose changes; planned changes to safety monitoring/reporting). Results are not available in the source record.
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?
Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. (time frame: 24 months). 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 28 Dec 2020.