Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer. The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
59
Placebo
0.02 mg/kg
0.10 mg/kg
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Whittingham Cancer Center
Norwalk, Connecticut, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
University of Illinois at Chicago
Chicago, Illinois, United States
James Graham Brown Cancer Center
Lousiville, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University in St Louis
St Louis, Missouri, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
...and 9 more locations
Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
Time frame: 7 Weeks
Efficacy of Oral Mucositis assessment will be completed by trained site personnel. The WHO score will be the primary measure and NCI CTCAE will be a secondary measure for assessing Oral Mucositis.
Time frame: 7 weeks
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