Clinical trial NCT01367990: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alopecia
Radiodermatitis
Keywords: alopecia
hair loss
prevention
radiotherapy
head & neck cancer
radiodermatitis
radiation dermatitis
radiation-induced alopecia
Lead sponsor: ProCertus BioPharm, Inc
Sponsor class: INDUSTRY
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
First posted: 2011-06-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Safety of daily topical application of norepinephrine to the radiation field.
timeFrame: 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:
measure: Efficacy of daily topical application of norepinephrine to the radiation field.
timeFrame: 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
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Nikhil Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: