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Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

Pain Clinical Trial

Official title:
RC11C3, Pilot Placebo-Controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome

Clinical Trial Summary

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.

Clinical Trial Description

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 patient-reported outcomes (PRO) incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles.

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02166385
Study type Interventional
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase N/A
Start date January 2012
View Details
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