Phase 3
Completed N=510
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Musculoskeletal Complications · Postoperative Pain · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00602420 ↗
Enrolled (actual)
510
Serious AEs
1.6%
Results posted
May 2015
Primary outcomePrimary: Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. — 6.04; 7.71 (Pain Scale Score)*Days — p=0.037
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. |
6.04; 7.71 | 0.037 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00602420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.