Conditions: Bone Pain in Stage I - III Breast Cancer
Keywords: Breast cancer Chemotherapy Neulasta Pegfilgrastim Naproxen Loratadine Non-steroidal antiinflammatory drug (NSAID) Anti-histamine Bone Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 600
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. arm 2: Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. arm 3: Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.

Interventions: intervention 1: Naproxen intervention 2: Loratadine intervention 3: Pegfilgrastim intervention 4: Chemotherapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy. intervention 4: The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.

Protocol document: