Exploratory Study of Norepinephrine to Prevent Alopecia in Head and Neck Cancer Patients Treated With Radiotherapy
This study has been terminated.
(Study site has terminated the study due to the complexity of the study)
Sponsor:
ProCertus BioPharm, Inc
Collaborator:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
ProCertus BioPharm, Inc
ClinicalTrials.gov Identifier:
NCT01367990
First received: June 5, 2011
Last updated: March 22, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alopecia Radiodermatitis |
Drug: Norepinephrine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by ProCertus BioPharm, Inc:
Primary Outcome Measures:
- Safety of daily topical application of norepinephrine to the radiation field. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]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. [ Time Frame: 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 3 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | April 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: Noradrenaline
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367990
Locations
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
Sponsors and Collaborators
ProCertus BioPharm, Inc
H. Lee Moffitt Cancer Center and Research Institute
Investigators
| Principal Investigator: | Nikhil Rao, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
No publications provided
| Responsible Party: | ProCertus BioPharm, Inc |
| ClinicalTrials.gov Identifier: | NCT01367990 History of Changes |
| Other Study ID Numbers: | PC-5 |
| Study First Received: | June 5, 2011 |
| Last Updated: | March 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ProCertus BioPharm, Inc:
|
alopecia hair loss prevention radiotherapy |
head & neck cancer radiodermatitis radiation dermatitis radiation-induced alopecia |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Head and Neck Neoplasms Radiodermatitis Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical Neoplasms by Site Neoplasms Dermatitis Radiation Injuries Wounds and Injuries Norepinephrine |
Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013