Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Status: | Completed |
---|---|
Conditions: | Cancer, Chronic Pain |
Therapuetic Areas: | Musculoskeletal, Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 4/21/2016 |
Start Date: | June 2008 |
End Date: | March 2012 |
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.
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.
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.
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
We found this trial at
16
sites
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CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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CCOP - Grand Rapids The Grand Rapids Clinical Oncology Program (GRCOP) is a community cancer...
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