Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

Condition(s) targeted: Pain; Peripheral Neuropathy

Intervention: pregabalin (Drug); placebo (Drug); questionnaire administration (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Academic and Community Cancer Research United

Official(s) and/or principal investigator(s):
Charles Loprinzi, Principal Investigator, Affiliation: Mayo Clinic

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.

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

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

Primary outcome: Number of patients pregabalin has any effect on the prevention of paclitaxel-associated acute pain syndrome (P-APS) at 180 days.

Secondary outcome:

Number of patients benefit of pregabalin on paclitaxel-induced peripheral neuropathy at 6 months.

Number of toxicities related to pregabalin therapy in this study situation at 6 months.

Detailed 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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age > or equal to 18 years

- Ability to complete questionnaires by themselves or with assistance Paclitaxel

at a dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of 12 weeks without any other concurrent therapy

- Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or

neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors).

- Life expectancy > 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for

women of childbearing potential only (per clinician discretion)

Exclusion Criteria:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate

contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects

- Previous diagnosis of diabetic or other peripheral neuropathy

- Current, planned or previous use, within last 6 months, of gabapentin or pregabalin

- History of allergic or other adverse reactions to gabapentin or pregabalin

- Significant renal insufficiency with a history of a creatinine clearance (CrCL) <

30ml/min

- Prior exposure to neurotoxic chemotherapy

- Seizure history

- Diagnosis of fibromyalgia

- Previous exposure to paclitaxel

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Mayo Clinic Clinical Trials Office, Phone: 507-538-7623
Charles L. Loprinzi, Principal Investigator

Starting date: January 2012
Last updated: January 28, 2013