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

ProCertus BioPharm

Status and phase

Terminated

Phase 1

Conditions

Alopecia

Radiodermatitis

Treatments

Drug: Norepinephrine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01367990

PC-5

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.