Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain, Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT01637077

Run by

Academic and Community Cancer Research United

People needed

46

Starts

2012-01-01

Expected to finish

2016-04-01

Last updated by the study team

2018-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Cancer Center of Kansas — Wichita, Kansas, United States
• Essentia Health-Duluth CCOP — Duluth, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
• Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• Marshfield Clinic - Marshfield Center — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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