Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
3 other identifiers
interventional
510
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2008
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
May 12, 2015
CompletedNovember 9, 2015
October 1, 2015
3.6 years
January 22, 2008
June 24, 2014
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.
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.
From baseline through day 5
Study Arms (2)
Naproxen
EXPERIMENTALPatients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Placebo
PLACEBO COMPARATORPatients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of a non-hematologic (non-myeloid) malignancy
- Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent
- Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia
- Creatinine ≤ 1.5 times upper limit of normal
- Able to understand English
- More than 6 months since prior surgery on the heart
You may not qualify if:
- Pregnant or nursing
- Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers
- Allergy to naproxen
- Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs
- Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis
- Concurrent steroids on a regular basis
- Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed
- Concurrent therapeutic doses of warfarin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gary Morrowlead
- National Cancer Institute (NCI)collaborator
Study Sites (16)
MBCCOP - Hawaii
Honolulu, Hawaii, 96813, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
CCOP - Evanston
Evanston, Illinois, 60201, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, 13215, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles E. Heckler, PhD, MS. Research Assistant Professor
- Organization
- University of Rochester Medical Center
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, URCC / University of Rochester NCORP Research Base
Study Record Dates
First Submitted
January 22, 2008
First Posted
January 28, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2012
Study Completion
March 1, 2012
Last Updated
November 9, 2015
Results First Posted
May 12, 2015
Record last verified: 2015-10