Pain Clinical Trial
Official title:
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not
yet known whether naproxen is more effective than a placebo in preventing bone pain caused
by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.
PURPOSE: This randomized phase III trial is studying naproxen to see how well it works
compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with
non-hematologic cancer undergoing chemotherapy.
OBJECTIVES:
Primary
- To compare the efficacy of daily administration of naproxen vs placebo in preventing or
reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in
patients with non-hematologic malignancies undergoing chemotherapy.
Secondary
- To identify potential risk factors for the development of PIBP.
- To identify potential clinical predictors for the response or failure to respond to
naproxen in preventing PIBP.
- To assess the toxicity of naproxen when administered in the preventive setting.
OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology
Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.
- Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is
administered (day 2, 3, or 4) and continuing for 5-8 days.
- Arm II: Patients receive matching placebo twice daily beginning on the day
pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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