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

NCT ID: NCT01367990

Last Updated: 2012-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Norepinephrine

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Noradrenaline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: collaborator

ProCertus BioPharm, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikhil Rao, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

PC-5

Identifier Type: -

Identifier Source: org_study_id