Spots Global Cancer Trial Database for Safety and Efficacy of RK0202 in Oral Mucositis
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Trial Identification
Brief Title: Safety and Efficacy of RK0202 in Oral Mucositis
Official Title: Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of RK-0202 on Oral Mucositis in Patients Receiving Radiation Therapy for Tumors of the Oral Cavity, Oropharynx, Nasopharynx, Salivary Glands or Supraglottic Region
Study ID: NCT00230191
Interventions
Study Description
Brief Summary: The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis in subjects receiving radiation therapy for head and neck cancer. Concurrent chemotherapy is not allowed in the study.
Detailed Description: Approximately 42,000 new cases of head and neck squamous cell carcinoma occur annually in the United States. Radiotherapy ("RT") plays a significant role in the management of head and neck cancer. The most common and clinically significant toxicities arising from head and neck radiation therapy are acute mucositis and acute and chronic xerostomia (dry mouth or salivary gland changes). In subjects receiving RT for cancers of the oral cavity or oropharynx the incidence of acute mucositis can exceed 90%. The painful ulceration of the oral mucosa produced by the radiation often leads to the requirement for narcotics to control pain, inability to eat, dehydration, the need for parenteral nutrition and, sometimes, breaks in RT. In addition to its symptomatic cost, the presence of mucositis has been associated with a number of other adverse outcomes including higher costs and more frequent hospitalizations.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Medical Center, Los Angeles, California, United States
H Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Commonwealth ENT, Louisville, Kentucky, United States
University of Connecticutt, Farmington, Massachusetts, United States
Medical University of Ohio, Cancer Institute Ruppert Cancer Center, Toledo, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Juravinski Cancer Center, Hamilton, Ontario, Canada
University of Ottawa, Ottawa, Ontario, Canada
Contact Details
Name: Steve Sonis, DMD DMSc
Affiliation: Harvard, Oral Medicine, Infection & Immunology
Role: STUDY_DIRECTOR
Name: Doug Peterson, DMD
Affiliation: University of Connecticutt Health Center
Role: PRINCIPAL_INVESTIGATOR
Name: Guy Juillard, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Chambers, DMD MS
Affiliation: MD Anderson
Role: PRINCIPAL_INVESTIGATOR
Name: Andy Trotti, MD
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: John Feldmeier, DO
Affiliation: Medical University of Ohio
Role: PRINCIPAL_INVESTIGATOR
Name: Samy El Sayed, MD
Affiliation: Ottawa Regional Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Rufus Scrimger, MD
Affiliation: Cross Cancer Institute, Edmonton, CA
Role: PRINCIPAL_INVESTIGATOR
Name: Jim Wright, MD
Affiliation: Juravinski Cancer Centre Hamilton Health Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Donald Welsh, MD
Affiliation: Commonwealth ENT, Louisville, KY
Role: PRINCIPAL_INVESTIGATOR
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