Overview

Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Academic and Community Cancer Research United
Treatments:
Paclitaxel
Pregabalin
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