Bone Pain - Clinical Trial (09-005)

URCC 07079 (NCI #URCC-06-06): Prevention of Pegfilgrastim-induced Bone Pain (PIBP) A Phase III Doubl-Blind Placebo-Controlled Clinical Trial

Protocol ID

09-005

Protocol Description

As part of standard of care, patients may receive a dose of pegfilgrastim (Neulasta®) on the day after they receive chemotherapy. The purpose of this injection of the pegfilgrastim  is to prevent or reduce the extent of chemotherapy-induced neutropenia (low white blood cell count). Up to 60% of patients who receive pegfilgrastim, develop pain in their bones or joints as a result of taking the medication. The pain is often mild and brief and confined to one area, but it can sometimes be severe and affect several areas or even all bones. At the present time, doctors cannot predict which patients will have pain or how severe it will be.

The purpose of the study is to compare the effects, good and/or bad, of naproxen or placebo on bone pain to find out which is better.  We also want to identify characteristics that might help predict which individuals might be more likely to develop bone pain and respond to the naproxen.

Eligibility Criteria

Patients receiving chemotherapy

Primary Investigator(s)

  • Vincent Vinciguerra, MD

Contact Information

Nanette Nier-Shoulson, RN
(516) 734-8918
nnier@nshs.edu

Last Update

November 11, 2009
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