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

NCT01367990 | Terminated Phase 1

• 1 other identifier: PC-5
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia; Radiodermatitis

Keywords

alopecia; hair loss; prevention; radiotherapy; head & neck cancer; radiodermatitis; radiation dermatitis; radiation-induced alopecia

Outcome Measures

Primary Outcomes (1)

• Safety of daily topical application of norepinephrine to the radiation field.

  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 Outcomes (1)

• Efficacy of daily topical application of norepinephrine to the radiation field.

  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

Study Arms (1)

Norepinephrine

EXPERIMENTAL

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

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).

Also known as: Noradrenaline

Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProCertus BioPharm, Inc: lead
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Alopecia; Radiodermatitis; Head and Neck Neoplasms

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Dermatitis; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nikhil Rao, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2011
• First Posted: June 7, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

US (1)