Study Complete
Sponsor ID
20040118
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects with Advanced Head and Neck Cancer
Study Details
The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.
Protocol Summary
Primary Outcome Measures
Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
Timeframe: Up to 24 weeks
Secondary Outcome Measures
Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with Head and Neck cancer [OMWQ-HN]
Timeframe: 16 weeks
Time to onset of severe oral mucositis (WHO Grades 3 or 4)
Timeframe: 12 weeks
Total dose of opioid analgesics used (mg of morphine equivalents)
Timeframe: 16 weeks
Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)
Timeframe: 12 weeks
Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)
Timeframe: 10 years
Duration of severe oral mucositis (WHO Grades 3 or 4)
Timeframe: 15 weeks
Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)
Timeframe: 12 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.