Bone Pain in Stage I - III Breast Cancer Clinical Trial
Official title:
Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.
In this study, the investigational products are naproxen, a non-steroidal antiinflammatory
drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as
prophylactic medications to reduce the incidence and/or severity of bone pain in breast
cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and
pegfilgrastim prophylaxis.
Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help
fight infections in patients undergoing chemotherapy.
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