Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
|ClinicalTrials.gov Identifier: NCT00602420|
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 12, 2015
Last Update Posted : November 9, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Complications Pain Unspecified Adult Solid Tumor, Protocol Specific||Drug: naproxen Other: placebo||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||510 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial|
|Study Start Date :||June 2008|
|Primary Completion Date :||January 2012|
|Study Completion Date :||March 2012|
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Oral naproxen twice daily for 5-8 days.
Placebo Comparator: Placebo
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Oral placebo twice daily for 5-8 days.
- Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. [ Time Frame: From baseline through day 5 ]Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602420
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|CCOP - Evanston|
|Evanston, Illinois, United States, 60201|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|St. Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|United States, New York|
|CCOP - Hematology-Oncology Associates of Central New York|
|Syracuse, New York, United States, 13215|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43215|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Washington|
|CCOP - Virginia Mason Research Center|
|Seattle, Washington, United States, 98101|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|United States, Wisconsin|
|CCOP - Marshfield Clinic Research Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Study Chair:||Jeffrey J. Kirshner, MD||CCOP - Hematology-Oncology Associates of Central New York|
|Study Chair:||Gary R. Morrow, PhD, MS||University of Rochester|
|Study Chair:||Jeffrey K. Giguere, MD, FACP||CCOP - Greenville|