Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Charles L. Loprinzi, M.D., (ACCRU), Academic and Community Cancer Research United
ClinicalTrials.gov Identifier:
NCT01637077
First received: March 9, 2012
Last updated: April 7, 2014
Last verified: April 2014

March 9, 2012
April 7, 2014
January 2012
November 2014   (final data collection date for primary outcome measure)
Number of patients pregabalin has any effect on the prevention of paclitaxel-associated acute pain syndrome (P-APS) at 180 days. [ Time Frame: From treatment initiation to 6 months. ] [ Designated as safety issue: No ]
Descriptive statistics and statistical plots will be mainly utilized. Means and 95% confidence intervals (CIs) will be estimated.
Same as current
Complete list of historical versions of study NCT01637077 on ClinicalTrials.gov Archive Site
  • Number of patients benefit of pregabalin on paclitaxel-induced peripheral neuropathy at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Number of toxicities related to pregabalin therapy in this study situation at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Pain
  • Peripheral Neuropathy
  • Drug: pregabalin
    Given PO
    Other Names:
    • 3-Isobutyl GABA
    • CI-1008
    • Lyrica
    • PD-144723
  • Drug: placebo
    Given PO
    Other Name: PLCB
  • Other: questionnaire administration
    Ancillary studies
  • Experimental: Arm I (pain therapy)
    Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
    Interventions:
    • Drug: pregabalin
    • Other: questionnaire administration
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
    Interventions:
    • Drug: placebo
    • Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
46
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01637077
RC11C3, NCI-2011-03646
Yes
Charles L. Loprinzi, M.D., (ACCRU), Academic and Community Cancer Research United
Academic and Community Cancer Research United
Not Provided
Principal Investigator: Charles Loprinzi Mayo Clinic
Academic and Community Cancer Research United
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP