LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients
Condition: Malignant Tumor of Ill-defined Site
MeSH terms: Neoplasms
Intervention: Pharmacogenomic Testing
Intervention description: Pharmacogenomic test results to guide drug/dose modifications
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: Enrolled subjects all receive pharmacogenomic testing with the intention of guiding pain management. This single-arm trial is testing against a published historical control.
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      About half of all cancer patients seen in oncology clinics have pain at initial assessment;
      pain relief within a one-month period is seen in approximately one third of these patients
      and pain worsening in about one fifth. Risk factors for under-treatment of cancer pain
      include age older than 65 years, minority status, and inadequate pain assessment practices.
      There is a need for better methods of opioid drug/dose selection and identification of risk
      factors for worsening pain. Pharmacogenomic approaches offer insight into the genetic
      variables that impact the pharmacokinetic and pharmacodynamic behavior of opioids.
      Translating pharmacogenomic results into actionable prescribing decisions may ultimately
      enable a personalized approach to pain management, increasing the chance of significant pain
      improvement. Cancer outpatients with uncontrolled malignant pain will be offered a
      pharmacogenomic test through participation in the study. The results of this test will be
      used to modify their pain regimen, if applicable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of uncontrolled malignant pain (score of greater than or equal to 2 on an 11
             point scale [0-10]) as diagnosed and assessed by the Investigator, using the Edmonton
             Symptom Assessment Scale (ESAS).

          -  Documentation of any stage of cancer of any tumor location (solid or hematological).

          -  At least 18 years of age.

          -  Either nociceptive or neuropathic pain.

          -  Able to understand and be willing to sign the study consent form.

        Exclusion Criteria:

          -  Inpatient service at baseline visit.

          -  Significant dysphagia and inability to swallow oral medications as determined by the
             Investigator.

          -  Active or recent (within one year) drug and/or alcohol abuse as determined by the
             Investigator.

          -  Significant baseline cognitive impairment, as determined by the Investigator. Known
             (anaphylactic) hypersensitivity to any opioid.

          -  Severe oral mucositis that would impair proper buccal testing as determined by the
             Investigator.

          -  Receiving concurrent rehabilitation medicine care, nociception modulation (e.g.,
             electrical stimulation), use of modalities with physiologic effects that indirectly
             influence nociception (e.g., light, laser therapy), or any other non-pharmacologic
             approaches to pain management other than exercise, rest, ice, compression, and
             elevation (RICE).

          -  Presence of major psychiatric disorders as determined by the Investigator.

          -  Receiving active treatment or prophylaxis for epilepsy.

          -  Unable or unwilling to sign the study consent form.