Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
Overview
- Phase
- Not Applicable
- Intervention
- Pregabalin
- Conditions
- Neuropathy
- Sponsor
- Washington University School of Medicine
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change in Spontaneous Pain Intensity as a Function of Baseline MPT
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Investigators
simon.haroutounian
Assistant Professor, Department of Anesthesiology
Washington University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Intervention: Pregabalin
Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Intervention: Placebo
Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Intervention: Pregabalin
Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Intervention: Placebo
Outcomes
Primary Outcomes
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
- Change in BPI Outcomes (INTERFERENCE)(baseline to week 4)
- Change in NPSI Outcomes(Baseline to week 4)
- Change in Sleep Problem Index (SPI) Outcomes(Baseline to week 4)
- Change in BPI Outcomes (SEVERITY)(Baseline to week 4)
- Number of Patients With Significant Pain Reduction(Baseline to week 4)
- Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)(Baseline to week 4)