Clinical trial · Interventional
LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients
LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Pilot Study of Pain Management in Oncology Outpatients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early study closure due to limited internal resources to continue enrollment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of Ill-defined Site | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pharmacogenomic Testing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pharmacogenomic Testing
- description
- Pharmacogenomic test results to guide drug/dose modifications
- interventionNames
- Genetic: Pharmacogenomic Testing
Primary outcomes (1)
- measure
- Rate of Pain Improvement as Measured Using the Edmonton Symptom Assessment Scale (ESAS) From Baseline Assessment (Day 0) to Final Assessment on Day 30 +/- 7
- timeFrame
- Enrollment to Final Assessment (30 +/- 7 days from Baseline Assessment (Day 0))
- description
- Proportion of subjects achieving significant pain improvement over a one month period (30 days +/- 7) (defined as a ≥ 2 point decrease from baseline pain score on an 11-point scale \[0-10\]) in oncology outpatients receiving pharmacogenomic testing.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPatel JN, Boselli D, Symanowski J, Wodarski S, Turner S, Slaughter C, Myers M, Edwards R, Susi B, Greiner R, Edelen C. Pilot study of multi-gene pharmacogenetic testing for pain management in oncology palliative medicine. Pharmacogenomics. 2021 Aug;22(12):737-748. doi: 10.2217/pgs-2021-0037. Epub 2021 Aug 20. PMID 34414777