Clinical trial NCT02394951
Conditions: Neuropathy Pain
Keywords: chemotherapy
Sponsor: Washington University School of Medicine
Start date: 2015-04-01; Completion date: 2018-04-02
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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).

Detailed description:

Arms: arm 1: Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day. arm 2: Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Anticonvulsant intervention 2: Identical, matching inactive substance

Protocol documents:
Prot_SAP_000.pdf: 
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