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
  Purpose

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.


Condition Intervention
Pain
Peripheral Neuropathy
Drug: pregabalin
Drug: placebo
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Academic and Community Cancer Research United:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 46
Study Start Date: January 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: pregabalin
Given PO
Other Names:
  • 3-Isobutyl GABA
  • CI-1008
  • Lyrica
  • PD-144723
Other: questionnaire administration
Ancillary studies
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.
Drug: placebo
Given PO
Other Name: PLCB
Other: questionnaire administration
Ancillary studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637077

Locations
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Minnesota
Essentia Health-Duluth CCOP
Duluth, Minnesota, United States, 55805
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Academic and Community Cancer Research United
Investigators
Principal Investigator: Charles Loprinzi Mayo Clinic
  More Information

No publications provided

Responsible Party: Charles L. Loprinzi, M.D., (ACCRU), Study Chair, Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT01637077     History of Changes
Other Study ID Numbers: RC11C3, NCI-2011-03646
Study First Received: March 9, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Pain
Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014