Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
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|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|
|Actual Primary Completion Date :||January 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|