Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00602420 |
|
Recruitment Status
:
Completed
First Posted
: January 28, 2008
Results First Posted
: May 12, 2015
Last Update Posted
: November 9, 2015
|
Sponsor:
Gary Morrow
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Musculoskeletal Complications Pain Unspecified Adult Solid Tumor, Protocol Specific | Drug: naproxen Other: placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 510 participants |
| Allocation: | Randomized |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Naproxen
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
|
Drug: naproxen
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.
|
Other: placebo
Oral placebo twice daily for 5-8 days.
|
Primary Outcome Measures
:
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
| 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 |
| Responsible Party: | Gary Morrow, Director, URCC / University of Rochester NCORP Research Base, University of Rochester NCORP Research Base |
| ClinicalTrials.gov Identifier: | NCT00602420 History of Changes |
| Other Study ID Numbers: |
CDR0000584341 U10CA037420 ( U.S. NIH Grant/Contract ) URCC-07079 ( Other Identifier: URCC ) |
| First Posted: | January 28, 2008 Key Record Dates |
| Results First Posted: | May 12, 2015 |
| Last Update Posted: | November 9, 2015 |
| Last Verified: | October 2015 |
Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:
|
pain musculoskeletal complications unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Naproxen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |