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

NCT01367990 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2012-03-23

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • ProCertus BioPharm, Inc

    lead INDUSTRY

Principal Investigators

  • Nikhil Rao, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01367990 on ClinicalTrials.gov