Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
Other: questionnaire administration
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome|
- 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 ]
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I (pain therapy)
Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Other Names:Other: questionnaire administration
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
Other Name: PLCBOther: questionnaire administration
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.
|United States, Kansas|
|Cancer Center of Kansas||Recruiting|
|Wichita, Kansas, United States, 67214|
|Contact: Pat Stone, R.N. 316-613-4313 email@example.com|
|Principal Investigator: Shaker R. Dakhil, M.D.|
|United States, Minnesota|
|Essentia Health-Duluth CCOP||Recruiting|
|Duluth, Minnesota, United States, 55805|
|Contact: Wilma Knutson, R.N. 218-786-3308 Wilma.firstname.lastname@example.org|
|Principal Investigator: Daniel A. Nikcevich, M.D., Ph.D.|
|Rochester, Minnesota, United States, 55905|
|Contact: Mayo Clinic Clinical Trials Office 507-538-7623|
|Principal Investigator: Charles L. Loprinzi|
|United States, Wisconsin|
|Marshfield Clinic - Marshfield Center||Not yet recruiting|
|Marshfield, Wisconsin, United States, 54449|
|Contact: Lori L. Fellenz, R.N. 800-782-8581 ext 9-4773 email@example.com|
|Principal Investigator: Ali W. Bseiso, M.D.|
|Principal Investigator:||Charles Loprinzi||Mayo Clinic|