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

March 22, 2012 updated by: ProCertus BioPharm, Inc

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Noradrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProCertus BioPharm, Inc

Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Nikhil Rao, MD, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

June 5, 2011

First Submitted That Met QC Criteria

June 5, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Estimate)

March 23, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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