RadiodermatitisPhase 1/2NCT01544504
Exploratory Study of Topical Norepinephrine in Breast Cancer Patients Receiving Radiotherapy
A Phase 1/2 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 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must:
- be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0), Stage IIA (T0-T1N1M0, T2N0M0) or Stage IIB (T2N1M0, T3N0M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS).
- be post-surgical patients scheduled to be treated with at least 50 Gy to the whole breast and axilla using standard radiation techniques (an additional 10-16 Gy boost to the lumpectomy region may also be delivered). All radiation treatment is to be delivered based on standard CT planning.
- be at higher than average risk for radiodermatitis, as evidenced by a separation at the posterior tangent field border of ≥ 24 cm or a bra cup size of C or greater [breast size criterion].
- have the ability to understand the informed consent document.
- be able to comply with protocol schedule.
- have a negative serum pregnancy test (within 7 days prior to starting radiation therapy), if a female of child bearing potential.
- consent to utilize medically acceptable methods of contraception throughout the study period if of child-bearing potential.
Who cannot join
- Subjects:
- with unhealed surgical wounds or scars in the study treatment area.
- 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.
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- with a known allergy to norepinephrine.
- with a known clinically significant abnormal ECG within the past 6 months. If the Principal Investigator feels that the ECG findings are of clinical significance, the patient will excluded or sent for a cardiac consult (insignificant abnormalities such as sinus tachycardia and sinus bradycardia may be allowed at the discretion of the Principal Investigator).
- 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 close proximity of the tumor to the overlying skin within the SDAS (as evidenced by a depth of less than 5 mm on ultrasound or MRI [if performed] and a linear distance of less than 2 cm from the SDAS), or a diagnosis of inflammatory breast cancer.
- receiving concurrent neoadjuvant or adjuvant chemotherapy for their breast cancer.
- with previous radiation to the breast to be treated.
- taking β-blockers.
- with NCI CTC Version 4.0 grade 2 or higher hypertension at the time of study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 333612
About this study
Official title: Exploratory Study of Topical Norepinephrine in Post-Surgical Breast Cancer Patients Receiving Radiotherapy
This study, a nonrandomized open-label 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 4.65 mL of a norepinephrine solution (400 mM, 82.3 mg/mL) will be applied topically to the study drug application site prior to each radiotherapy treatment (approximately 25-28 treatments).
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Experimental | Topical norepinephrine 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 for up to 11 weeks following the start of treatment.
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 for up to 11 weeks following the start of treatment..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: The principal investigator withdrew from the study. The study was withdrawn because a qualified replacement was not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProCertus BioPharm, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
- Investigators
- Eleanor Harris, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544504
- Sponsor's protocol ID
- PC-6
- Status last verified
- May 2012
- First submitted
- 15 Feb 2012
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. 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
- NCT01544504
- Acronym / sponsor ID
- PC-6
- Conditions
- Radiodermatitis
- Keywords
- Radiodermatitis, Prevention, Radiotherapy, Breast, Radiation Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The principal investigator withdrew from the study. The study was withdrawn because a qualified replacement was not available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProCertus BioPharm, IncIndustry (pharma, biotech, devices)
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Mar 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.
This study, a nonrandomized open-label 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Experimental | Drug: NorepinephrineTopical norepinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- be ≥ age 18 years of age with a documented pathological diagnosis of Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0), Stage IIA (T0-T1N1M0, T2N0M0) or Stage IIB (T2N1M0, T3N0M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS).
- be post-surgical patients scheduled to be treated with at least 50 Gy to the whole breast and axilla using standard radiation techniques (an additional 10-16 Gy boost to the lumpectomy region may also be delivered). All radiation treatment is to be delivered based on standard CT planning.
- be at higher than average risk for radiodermatitis, as evidenced by a separation at the posterior tangent field border of ≥ 24 cm or a bra cup size of C or greater [breast size criterion].
- have the ability to understand the informed consent document.
- be able to comply with protocol schedule.
Key exclusion criteria (17 listed)
- with unhealed surgical wounds or scars in the study treatment area.
- 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.
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 4.65 mL of a norepinephrine solution (400 mM, 82.3 mg/mL) will be applied topically to the study drug application site prior to each radiotherapy treatment (approximately 25-28 treatments). | Drug | Norepinephrine |
Primary outcome
Safety of daily topical application of norepinephrine to the radiation field
Time frame: Safety will be assessed for up to 11 weeks following the start of treatment.
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 for up to 11 weeks following the start of treatment..
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
Eleanor Harris, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 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 8 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: withdrawn, as of the sponsor's last update on 28 May 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 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 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 was withdrawn before enrolling participants, so there are no results.
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 for up to 11 weeks following the start of treatment.). 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 May 2012.