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Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)


Phase 1
18 Years
N/A
Not Enrolling
Both
Alopecia, Radiodermatitis

Thank you

Trial Information

Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Safety of daily topical application of norepinephrine to the radiation field.

Outcome Description:

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.

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Nikhil Rao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

PC-5

NCT ID:

NCT01367990

Start Date:

July 2011

Completion Date:

April 2012

Related Keywords:

  • Alopecia
  • Radiodermatitis
  • alopecia
  • hair loss
  • prevention
  • radiotherapy
  • head & neck cancer
  • radiodermatitis
  • radiation dermatitis
  • radiation-induced alopecia
  • Alopecia
  • Alopecia Areata
  • Head and Neck Neoplasms
  • Radiodermatitis

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612