Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

• Number of patients pregabalin has any effect on the prevention of paclitaxel-associated acute pain syndrome (P-APS) at 180 days. [ Time Frame: From treatment initiation to 6 months. ] [ Designated as safety issue: No ]
  Descriptive statistics and statistical plots will be mainly utilized. Means and 95% confidence intervals (CIs) will be estimated.
  
  

• Number of patients benefit of pregabalin on paclitaxel-induced peripheral neuropathy at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ] [ Designated as safety issue: No ]
  
• Number of toxicities related to pregabalin therapy in this study situation at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ] [ Designated as safety issue: No ]
  

PRIMARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (P-APS). SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy. II. To obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation. TERTIARY OBJECTIVES: I. To characterize neurological testing abnormalities that might occur with the P-APS, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (CIPN). II. To determine the PRO incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles. These data will serve to confirm the results obtained in our previous natural history study N08C1. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pregabalin orally (PO) twice daily (BID), beginning on the first night of chemotherapy, for 12 weeks and then once daily (QD) for 1 week. ARM II: Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. After completion of study treatment, patients are followed up every 30 days for 6 months.