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
  Purpose

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.


Condition Intervention Phase
Alopecia
Radiodermatitis
Drug: Norepinephrine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)

Resource links provided by NLM:


Further study details as provided by ProCertus BioPharm, Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 3
Study Start Date: July 2011
Estimated Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norepinephrine 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367990

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
ProCertus BioPharm, Inc
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Nikhil Rao, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

Responsible Party: ProCertus BioPharm, Inc
ClinicalTrials.gov Identifier: NCT01367990     History of Changes
Other Study ID Numbers: PC-5
Study First Received: June 5, 2011
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ProCertus BioPharm, Inc:
alopecia
hair loss
prevention
radiotherapy
head & neck cancer
radiodermatitis
radiation dermatitis
radiation-induced alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Head and Neck Neoplasms
Radiodermatitis
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Neoplasms by Site
Neoplasms
Dermatitis
Radiation Injuries
Wounds and Injuries
Norepinephrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014