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A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes


Phase 1
18 Years
80 Years
Not Enrolling
Both
Mucositis, Stomatitis

Thank you

Trial Information

A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes


Inclusion Criteria:



- cancer patients scheduled to receive at least 5 weeks of radiation therapy to the
sub-mandibular lymph nodes

- normal ECG

- normal blood pressure

Exclusion Criteria:

- untreated cardiac disease

- connective tissue disorders

- open sores, wound, ulcerations to oral cavity

- allergy to phenylephrine

- know untreated hypertensin

- abnormal ECG in past 6 months

- taking prescription monoamine oxidase inhibitor (MAOI)

- are pregnant

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.

Outcome Time Frame:

24 months

Safety Issue:

Yes

Principal Investigator

James F Cleary, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

CO09901

NCT ID:

NCT01092975

Start Date:

March 2010

Completion Date:

April 2011

Related Keywords:

  • Mucositis
  • Stomatitis
  • radiotherapy
  • Stomatitis
  • Mucositis

Name

Location

University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669