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LCI-NOS-PAIN-001: A Prospective, Pharmacogenomic-Driven Study of Pain Management in Oncology Outpatients

NCT02542397 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-11-03

Study results available
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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.

Conditions

  • Malignant Tumor of Ill-defined Site

Interventions

GENETIC

Pharmacogenomic Testing

Pharmacogenomic test results to guide drug/dose modifications

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jai Patel, PharmD · Atrium Health Levine Cancer Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02542397 on ClinicalTrials.gov