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Sponsored by: |
RxKinetix |
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Information provided by: | RxKinetix |
ClinicalTrials.gov Identifier: | NCT00230191 |
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.
Condition | Intervention | Phase |
---|---|---|
Mouth Diseases Mouth Ulcers Oral Mucositis Head and Neck Cancer |
Drug: RK-0202 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 110 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | December 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
United States, Florida | |
H Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 | |
United States, Kentucky | |
Commonwealth ENT | |
Louisville, Kentucky, United States, 40207 | |
United States, Massachusetts | |
University of Connecticutt | |
Farmington, Massachusetts, United States, 06030 | |
United States, Ohio | |
Medical University of Ohio, Cancer Institute Ruppert Cancer Center | |
Toledo, Ohio, United States, 43614 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G1Z2 | |
Canada, Ontario | |
University of Ottawa | |
Ottawa, Ontario, Canada, K1H1C4 | |
Juravinski Cancer Center | |
Hamilton, Ontario, Canada, L8V5C2 |
Study Director: | Steve Sonis, DMD DMSc | Harvard, Oral Medicine, Infection & Immunology |
Principal Investigator: | Doug Peterson, DMD | University of Connecticutt Health Center |
Principal Investigator: | Guy Juillard, MD | University of California, Los Angeles |
Principal Investigator: | Mark Chambers, DMD MS | MD Anderson |
Principal Investigator: | Andy Trotti, MD | H. Lee Moffitt Cancer Center and Research Institute |
Principal Investigator: | John Feldmeier, DO | Medical University of Ohio |
Principal Investigator: | Samy El Sayed, MD | Ottawa Regional Cancer Centre |
Principal Investigator: | Rufus Scrimger, MD | Cross Cancer Institute, Edmonton, CA |
Principal Investigator: | Jim Wright, MD | Juravinski Cancer Centre Hamilton Health Sciences |
Principal Investigator: | Donald Welsh, MD | Commonwealth ENT, Louisville, KY |
Study ID Numbers: | RK:0202-02 |
Study First Received: | September 28, 2005 |
Last Updated: | January 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00230191 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Oral Mucositis Stomatitis Head and Neck Cancer |
Mouth Diseases Oral Ulcer Digestive System Diseases Stomatitis Mucositis Gastrointestinal Diseases |
Ulcer Head and Neck Neoplasms Stomatognathic Diseases Gastroenteritis Salivary Gland Diseases |
Neoplasms Neoplasms by Site |