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

Alopecia Clinical Trial

Official title:

Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01367990
• Other study ID #: PC-5
• Status: Terminated
• Phase: Phase 1
• First received: June 5, 2011
• Last updated: March 22, 2012
• Start date: July 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2012
• Source: ProCertus BioPharm, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-blockers

• with NCI-CTCAE Version 4.0 grade 2 or higher hypertension at the time of study entry.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Head and Neck Neoplasms
• Radiodermatitis

Intervention

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).

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
ProCertus BioPharm, Inc	H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Efficacy of daily topical application of norepinephrine to the radiation field.	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	No