RadiodermatitisPhase 1NCT01263366
Exploratory Study of Norepinephrine to Prevent Radiodermatitis in Breast Cancer Patients
A Phase 1 study testing Norepinephrine in people with Radiodermatitis, run by ProCertus BioPharm, Inc at 1 site in United States.
Trial summary
This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiodermatitis
- What is being tested?
- Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects:
- with unhealed surgical wounds or scars in the study treatment area (axilla).
- with underlying active untreated cardiac disease (e.g. arrhythmia).
- with generalized skin disorders that have required treatment within the past 6 months.
- with connective tissue disorders.
- with rashes, ulcerations, or poorly healed scars in the study drug application area (axilla).
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- with a known allergy to norepinephrine.
- with known uncontrolled hypertension (repeatedly elevated BP; systolic BP >139 or diastolic BP >89).
- with a known clinically significant abnormal ECG within the past 6 months.
- receiving MAO inhibitors or antidepressants (triptyline or imipramine types).
- who are pregnant or breastfeeding.
- with lymphovascular space invasion on pathology.
- with dermal lymphatic invasion on pathology.
- with proximity of the tumor to the overlying skin as evidenced by a distance of less than 5 mm on US or MRI (if performed) and within 2 cm of the anticipated application field
- diagnosis of inflammatory breast cancer.
- receiving chemotherapy other than Herceptin concurrent with the radiation.
- with previous radiation to the breast to be treated.
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: Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy
This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy.
The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation dermatitis experienced by these patients.
- Conditions
- Radiodermatitis
- Being tested
- Norepinephrine
- Keywords
- Radiodermatitis, Prevention, Radiotherapy, Breast, Radiation Dermatitis
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Noradrenaline
Approximately 1.6 or 4.6 mL of a 400 mM norepinephrine solution will be applied topically to a portion of the radiation treatment field prior to each radiation treatment (20-33 treatments)
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Experimental | Not described Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of daily topical application of norepinephrine to the radiation field
The primary safety hypothesis is that there will be little or no skin irritation associated with the application of the topical norepinephrine and no systemic effects secondary to transdermal absorption.
Measured: Safety will be assessed during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period.
Secondary outcomes (1)
Efficacy of daily topical application of norepinephrine to the radiation field
The primary efficacy hypothesis is that the portion of the radiation site that is treated with topical norepinephrine immediately prior to daily radiotherapy will have less severe radiation dermatitis than the adjacent untreated portion of the radiation site.
Measured: Efficacy will be assessed during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Enrollment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiodermatitisStudies 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProCertus BioPharm, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- James F Cleary, MBBS, Principal investigator, University of Wisconsin, MadisonBethany M Anderson, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263366
- Sponsor's protocol ID
- PC-4
- Status last verified
- Apr 2013
- First submitted
- 16 Dec 2010
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cleary JF, Anderson BM, Eickhoff JC, Khuntia D, Fahl WE. Significant suppression of radiation dermatitis in breast cancer patients using a topically applied adrenergic vasoconstrictor. Radiat Oncol. 2017 Dec 22;12(1):201. doi: 10.1186/s13014-017-0940-7.
PubMed 29273054
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy
- ClinicalTrials.gov ID
- NCT01263366
- Acronym / sponsor ID
- PC-4
- Conditions
- Radiodermatitis
- Keywords
- Radiodermatitis, Prevention, Radiotherapy, Breast, Radiation Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment issues
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ProCertus BioPharm, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Dec 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.
This study, a nonrandomized open-label Phase I safety and exploratory study, will evaluate the safety of topical norepinephrine in post-surgical breast cancer patients who are undergoing radiation therapy.
The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation dermatitis experienced by these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Experimental | Drug: Norepinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- with unhealed surgical wounds or scars in the study treatment area (axilla).
- with underlying active untreated cardiac disease (e.g. arrhythmia).
- with generalized skin disorders that have required treatment within the past 6 months.
- with connective tissue disorders.
- with rashes, ulcerations, or poorly healed scars in the study drug application area (axilla).
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 |
|---|---|---|
| NorepinephrineAlso: NoradrenalineApproximately 1.6 or 4.6 mL of a 400 mM norepinephrine solution will be applied topically to a portion of the radiation treatment field prior to each radiation treatment (20-33 treatments) | Drug | Norepinephrine |
Primary outcome
Safety of daily topical application of norepinephrine to the radiation field
Time frame: Safety will be assessed during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period.
The primary safety hypothesis is that there will be little or no skin irritation associated with the application of the topical norepinephrine and no systemic effects secondary to transdermal absorption.
1 secondary outcome
Efficacy of daily topical application of norepinephrine to the radiation field
Time frame: Efficacy will be assessed during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period.
Results and safety
The study was stopped early (reason given: Enrollment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- Derived from this study: PubMed 29273054Cleary JF, Anderson BM, Eickhoff JC, Khuntia D, Fahl WE. Significant suppression of radiation dermatitis in breast cancer patients using a topically applied adrenergic vasoconstrictor. Radiat Oncol. 2017 Dec 22;12(1):201. doi: 10.1186/s13014-017-0940-7.
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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
Bethany M Anderson, MD study chair
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 Norepinephrine in people with Radiodermatitis, run by ProCertus BioPharm, Inc 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 0 inclusion and 17 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 19 Apr 2013. 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: Enrollment issues). 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 of daily topical application of norepinephrine to the radiation field (time frame: Safety will be assessed during the study (5-7 weeks) and at follow-up visits approximately 1, 2 and 4 weeks after the end of the treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263366, which also lists 1 linked publication.
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 19 Apr 2013.