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

Sponsor

ProCertus BioPharm, Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT01367990

Collaborator

H. Lee Moffitt Cancer Center and Research Institute (Other)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Radiodermatitis	Drug: Norepinephrine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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)

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Anticipated Study Completion Date :

Apr 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.