AlopeciaPhase 1NCT01367990
Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy
A Phase 1 study testing Norepinephrine in people with Alopecia and Radiodermatitis, run by ProCertus BioPharm, Inc at 1 site in United States.
Trial summary
The study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (IMRT). The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia, Radiodermatitis
- What is being tested?
- Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be ≥ 18 years of age with documented pathological diagnosis of H\&N (head and neck) cancer.
- planned to receive H\&N region IMRT treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to be at least 20 Gy.
- have a palpable nuchal prominence (external occipital protuberance)
- have the ability to understand the informed consent document.
- be able to comply with protocol schedule.
- have a negative serum pregnancy test if a female of childbearing potential.
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- consent to utilize medically acceptable methods of contraception throughout the study if of childbearing potential.
- be treated with IMRT alone or with concurrent platinum based chemotherapy
- receive definitive treatment for oropharyngeal squamous cell carcinoma
Who cannot join
- with clinical or radiographic evidence of adenopathy to the high level V posterior cervical nodes, post-auricular or occipital cervical nodal stations
- planned to receive H\&N region treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to exceed 50Gy
- with underlying active untreated cardiac disease (e.g. arrhythmia)
- receiving concurrent chemotherapy other than single agent platinum based
- with generalized skin disorders that have required treatment within the past 6 months.
- with connective tissue disorders
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- with unhealed wounds or scars in the study area
- with rashes, ulcerations, or poorly healed scars in the treatment area
- with a known allergy to norepinephrine
- with a known clinically significant abnormal ECG (electrocardiogram) within the past 6 months.
- taking MAO (monoamine oxidase) inhibitors or antidepressants of the triptyline or imipramine types
- taking β-blockers
- with NCI-CTCAE 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, 33612
About this study
Official title: Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)
The study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (IMRT).
The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia experienced by these patients.
- Conditions
- Alopecia, Radiodermatitis
- Being tested
- Norepinephrine
- Keywords
- alopecia, hair loss, prevention, radiotherapy, head & neck cancer, radiodermatitis, radiation dermatitis, radiation-induced alopecia
- Medical subject headings
- Alopecia, Radiodermatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Noradrenaline
The occipital scalp zone at risk for alopecia will be identified. The norepinephrine treatment site will be randomized to receive consistent treatment of one half of the scalp "risk zone." Approximately 1.6 mL of a 400 mM norepinephrine solution will be applied topically to the norepinephrine site approximately 20 minutes prior to each radiation treatment, and placebo will be applied to the contralateral side (30-35 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 that there will be little or no scalp irritation associated with the application of the topical norepinephrine and that there will be no systemic effects secondary to transdermal absorption.
Measured: Safety will be assessed during the study (6-7 weeks) and at follow-up visits approximately 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 areas of the scalp that are treated with topical norepinephrine immediately prior to intensity modulated radiotherapy (IMRT) will have less severe alopecia than scalp sites that are not treated with topical norepinephrine and that receive only placebo.
Measured: Efficacy will be assessed during the study (6-7 weeks) and at follow-up visits approximately 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 posted7 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionApr 2012 (estimated)
Why it stopped: Study site has terminated the study due to the complexity of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies 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
- 3 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
- Nikhil Rao, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367990
- Sponsor's protocol ID
- PC-5
- Status last verified
- Mar 2012
- First submitted
- 5 Jun 2011
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)
- ClinicalTrials.gov ID
- NCT01367990
- Acronym / sponsor ID
- PC-5
- Conditions
- Alopecia, Radiodermatitis
- Keywords
- alopecia, hair loss, prevention, radiotherapy, head & neck cancer, radiodermatitis, radiation dermatitis, radiation-induced alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study site has terminated the study due to the complexity of the study
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ProCertus BioPharm, IncIndustry (pharma, biotech, devices)
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (estimated)
- First posted
- 7 Jun 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 study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (IMRT).
The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia 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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be ≥ 18 years of age with documented pathological diagnosis of H\&N (head and neck) cancer.
- planned to receive H\&N region IMRT treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to be at least 20 Gy.
- have a palpable nuchal prominence (external occipital protuberance)
- have the ability to understand the informed consent document.
- be able to comply with protocol schedule.
Key exclusion criteria (13 listed)
- with clinical or radiographic evidence of adenopathy to the high level V posterior cervical nodes, post-auricular or occipital cervical nodal stations
- planned to receive H\&N region treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to exceed 50Gy
- with underlying active untreated cardiac disease (e.g. arrhythmia)
- receiving concurrent chemotherapy other than single agent platinum based
- with generalized skin disorders that have required treatment within the past 6 months.
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: NoradrenalineThe occipital scalp zone at risk for alopecia will be identified. The norepinephrine treatment site will be randomized to receive consistent treatment of one half of the scalp "risk zone." Approximately 1.6 mL of a 400 mM norepinephrine solution will be applied topically to the norepinephrine site approximately 20 minutes prior to each radiation treatment, and placebo will be applied to the contralateral side (30-35 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 (6-7 weeks) and at follow-up visits approximately 2 and 4 weeks after the end of the treatment period.
The primary safety hypothesis is that there will be that there will be little or no scalp irritation associated with the application of the topical norepinephrine and that there will be 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 (6-7 weeks) and at follow-up visits approximately 2 and 4 weeks after the end of the treatment period
Results and safety
The study was stopped early (reason given: Study site has terminated the study due to the complexity of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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.
Nikhil Rao, 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 study testing Norepinephrine in people with Alopecia and 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 9 inclusion and 13 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 23 Mar 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 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: Study site has terminated the study due to the complexity of the study). 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 (6-7 weeks) and at follow-up visits approximately 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?
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 23 Mar 2012.