RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
18 Years
N/A
Both
Pain, Peripheral Neuropathy
Trial Information
RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Number of patients pregabalin has any effect on the prevention of paclitaxel-associated acute pain syndrome (P-APS) at 180 days.
Outcome Description:
Descriptive statistics and statistical plots will be mainly utilized. Means and 95% confidence intervals (CIs) will be estimated.
Outcome Time Frame:
From treatment initiation to 6 months.
Safety Issue:
No
Principal Investigator
Charles Loprinzi
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
RC11C3
NCT ID:
NCT01637077
Start Date:
January 2012
Completion Date:
Related Keywords:
- Pain
- Peripheral Neuropathy
- Peripheral Nervous System Diseases
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| Essentia Health-Duluth CCOP | Duluth, Minnesota 55805 |
