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Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy

This study has been terminated.
(Study site has terminated the study due to the complexity of the study)
Sponsor:
Collaborator:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
ProCertus BioPharm, Inc
ClinicalTrials.gov Identifier:
NCT01367990
First received: June 5, 2011
Last updated: March 22, 2012
Last verified: March 2012

June 5, 2011
March 22, 2012
July 2011
February 2012   (final data collection date for 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. ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01367990 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Alopecia
  • Radiodermatitis
Drug: Norepinephrine
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).
Other Name: Noradrenaline
Experimental: Norepinephrine
Intervention: Drug: Norepinephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
April 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01367990
PC-5
No
ProCertus BioPharm, Inc
ProCertus BioPharm, Inc
H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: Nikhil Rao, MD H. Lee Moffitt Cancer Center and Research Institute
ProCertus BioPharm, Inc
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP