Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy
Information source: ProCertus BioPharm, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alopecia; Radiodermatitis
Intervention: Norepinephrine (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: ProCertus BioPharm, Inc Official(s) and/or principal investigator(s):
Nikhil Rao, MD, Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute
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.
Clinical Details
Official title: Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Safety of daily topical application of norepinephrine to the radiation field.
Secondary outcome: Efficacy of daily topical application of norepinephrine to the radiation field.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States
Additional Information
Starting date: July 2011
Last updated: March 22, 2012
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