Conditions: Musculoskeletal Complications Pain Unspecified Adult Solid Tumor, Protocol Specific
Keywords: pain musculoskeletal complications unspecified adult solid tumor, protocol specific
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 510
Healthy volunteers: no

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.

Detailed description:
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.

Arms:
arm 1: 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 2: 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.

Interventions: intervention 1: naproxen intervention 2: placebo
Intervention descriptions: intervention 1: Oral naproxen twice daily for 5-8 days. intervention 2: Oral placebo twice daily for 5-8 days.

Protocol document: