RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Number of patients pregabalin has any effect on the prevention of paclitaxel-associated acute pain syndrome (P-APS) at 180 days.
Descriptive statistics and statistical plots will be mainly utilized. Means and 95% confidence intervals (CIs) will be estimated.
From treatment initiation to 6 months.
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|
|Marshfield Clinic - Marshfield Center||Marshfield, Wisconsin 54449|
|Cancer Center of Kansas||Wichita, Kansas 67214|
|Essentia Health-Duluth CCOP||Duluth, Minnesota 55805|