Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Creatinine ≤ 1.5 times upper limit of normal

- Able to understand English

- No clinical evidence of active gastrointestinal bleeding, prior gastrointestinal
bleeding, or gastric or duodenal ulcers

- No known allergy to naproxen

- No prior development of the triad of asthma, rhinitis, and nasal polyps after taking
acetylsalicylic acid (aspirin) or other NSAIDs

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 6 months since prior surgery on the heart

- No 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

- No concurrent steroids on a regular basis

- No concurrent prescription or non-prescription medications for preexisting chronic
pain

- Concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed

- No concurrent therapeutic doses of warfarin