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Completed

NCT Number: NCT02394951

Pregabalin in CIPN

The investigators seek to investigate certain patient characteristics that would predict the response to a currently approved analgesic, pregabalin, in patients with chronic pain due to nerve damage caused by chemotherapy. Patients with this painful condition, called chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The investigators will recruit potential subjects from both the Siteman Cancer Center and the Washington University Pain Management Center. Those patients who meet the inclusion and satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and thermal sensitivity testing on their extremities, will provide quality of life information by completing questionnaires and will receive pregabalin followed by placebo, or placebo followed by pregabalin [crossover design] in order to assess how well the sensory tests predict the analgesic effect of pregabalin (compared to placebo).

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Key information

Conditions

Neuropathy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18
  • Distal symmetric pain distribution (both feet, with or without pain in hands).
  • The pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these.
  • Score of 4 or more on DN4 (Douleur Neuropathique 4) neuropathic pain questionnaire
  • Pain duration > 2 months.
  • Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation.
  • Able and willing to sign an IRB-approved written informed consent.

Exclusion criteria

  • Hypersensitivity to pregabalin.
  • Current treatment with pregabalin.
  • Current treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or CIPN that may be associated with previous treatment with a vinca alkaloid.
  • History of diabetes mellitus or a neurological disorder with any previous signs of distal symmetric polyneuropathy.
  • Moderate to severe renal failure (Creatinine clearance < 30mL/min, by Cockcroft-Gault formula).
  • ALT (alanine aminotransferase) or AST (aspartate aminotransferase ) > 3 times the upper limit of normal.
  • Planned surgeries or radiation treatment within 10 weeks following study inclusion.
  • Inability to complete pain self-report.
  • Pregnancy or lactation
  • Patients with seizure disorders treated with anticonvulsants
  • Current participation in a trial with another investigational agent.
  • Concomitant medication as follows:
  • Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation.
  • Patients on antidepressant treatment for pain or depression (TCAs, SSRI, SNRIs etc. will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation. No dose regimen changes of antidepressants will be allowed during the study period.
  • Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation. The maximum allowed dose of opioid will be equivalent to 60mg oral morphine sulphate. Patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study. Short-acting opioids for painful CIPN treatment will not be allowed.
  • Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) will be discontinued at least 2 weeks before study initiation. However, low-dose aspirin (≤325mg/day) will be allowed.

Treatment and study plan

Pregabalin

Drug

Anticonvulsant

Other names: Lyrica

Placebo

Drug

Identical, matching inactive substance

Primary outcomes

  1. Change in Spontaneous Pain Intensity as a Function of Baseline MPT

    Time frame: Baseline to week 4

    Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.

Secondary outcomes

  1. Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)

    Time frame: Baseline to week 4

    Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain

  2. Change in NPSI Outcomes

    Time frame: Baseline to week 4

    Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score

  3. Change in BPI Outcomes (SEVERITY)

    Time frame: Baseline to week 4

    Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity

  4. Change in Sleep Problem Index (SPI) Outcomes

    Time frame: Baseline to week 4

    Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score

  5. Change in BPI Outcomes (INTERFERENCE)

    Time frame: baseline to week 4

    Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference

  6. Number of Patients With Significant Pain Reduction

    Time frame: Baseline to week 4

    Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2015
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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