Back to resultsExploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy
Primary Purpose
Alopecia, Radiodermatitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Norepinephrine
Sponsored by
About this trial
This is an interventional supportive care trial for Alopecia focused on measuring alopecia, hair loss, prevention, radiotherapy, head & neck cancer, radiodermatitis, radiation dermatitis, radiation-induced alopecia
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Norepinephrine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01367990
First Posted
June 5, 2011
Last Updated
March 22, 2012
Sponsor
ProCertus BioPharm, Inc
Collaborators
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01367990
Brief Title
Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy
Official Title
Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Study site has terminated the study due to the complexity of the study
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProCertus BioPharm, Inc
Collaborators
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 experienced by these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Radiodermatitis
Keywords
alopecia, hair loss, prevention, radiotherapy, head & neck cancer, radiodermatitis, radiation dermatitis, radiation-induced alopecia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Norepinephrine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Noradrenaline
Intervention Description
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).
Primary Outcome Measure Information:
Title
Safety of daily topical application of norepinephrine to the radiation field.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Efficacy of daily topical application of norepinephrine to the radiation field.
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Rao, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy
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