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

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.