Clinical Trials Logo
  1. Home
  2. Mucositis
  3. NCT01092975
  4. Details
NCT01092975 Clinical Trial

Safety of Phenylephrine for Oral Mucositis Prevention

Mucositis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01092975
Other study ID # H-2009-0077
Secondary ID NCI-2011-00742CO
Status Terminated
Phase Phase 1
First received
Last updated
Start date March 2010
Est. completion date April 2011

Study information
Verified date December 2020
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date April 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• phenylephrine solution
Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.

Locations
Country Name City State
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine. 24 months
Secondary Efficacy: the the mucositis severity area-under-the-curve (AUC) where the severity of oral mucositis on each treatment day will be scored, summed, and plotted graphically. 24 months
See also
  Status Clinical Trial Phase
Completed NCT02252926 - Local Anesthetic Treatment of Oral Pain in Patients With Mucositis Phase 2
Completed NCT01155609 - L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer N/A
Completed NCT00357942 - Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy Phase 4
Completed NCT00360685 - Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX N/A
Completed NCT04586491 - The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients N/A
Withdrawn NCT02589860 - Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
Not yet recruiting NCT02506231 - The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome Phase 2/Phase 3
Completed NCT02605382 - Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis Phase 2
Completed NCT02639377 - Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis Phase 2
Terminated NCT02575313 - The Effects of Whole Food Intervention on Mucositis in Patients Treated for Head and Neck Cancer Phase 1/Phase 2
Completed NCT00956254 - Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis Phase 3
Completed NCT00584597 - A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis Phase 1
Enrolling by invitation NCT05590117 - Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer Early Phase 1
Completed NCT05635929 - Oral Mucositis and Quality of Life With a Mucosa Topical Composition in Head & Neck Cancer Patients. N/A
Completed NCT05181943 - Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis N/A
Completed NCT03713567 - Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis N/A
Completed NCT02671812 - Outcome After Dental Implant Treatment
Terminated NCT02273752 - Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer Phase 2
Recruiting NCT01707641 - Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer Phase 4
Completed NCT01015183 - Prevention Chemotherapy Induced Mucositis by Zinc Sulfate Phase 2/Phase 3

External Links