Informing Pain Treatment Using Pharmacogenomic Analysis (C-PAIN)

C-PAIN: Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment

This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.

Study Overview

• Status: Recruiting
• Conditions: Adult Patients Who Are Receiving Oncologic Care
• Intervention / Treatment: Other: Pharmacogenomic (PGx) results.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Intake; Phone Number: 1-855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine Comprehensive Cancer Center
      • Principal Investigator: Peter O'Donnell
      • Contact: Clinical Trials Intake; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Persons receiving ongoing oncology care at the University of Chicago Medical Center for whom near-future pain opioid pain medication therapy is anticipated
• Subjects must be at least 18 years of age.

Exclusion Criteria:

• Subjects taking an opioid at the time of enrollment, or within the past 30 days
• Subjects who are currently undergoing palliative radiation
• Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
• Subjects with a history of or active blood cancer (e.g., leukemia).
• Chronic kidney disease, as defined by Glomerular filtration rate (GFR) < 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
• Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin greater than or equal to1.5 mg/dL, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) greater than or equal to 2.5 X upper limit of normal*. (*Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \ greater than or equal to 5 X upper limit of normal if hepatic metastases are present).
• Inability to understand and give informed consent to participate in the opinion of the investigator
• Subjects who are known to be pregnant at the time of enrollment
• Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PGx Arm; PGX information is provided to clinicals to inform opioid dosing and selection.	Other: Pharmacogenomic (PGx) results.; These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
No Intervention: Control Arm; No PGX information provided opioid dosing and selection is according to standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain control.	Measuring changes in composite pain intensity rating via the numeric rating scale: Brief Pain Inventory-Short Form (BPI-SF); Score range: 0 (no pain) to 10 (most pain); Composite pain intensity score (mean of worst, least, average, and current pain) From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone.	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Medication Regimen Changes	Pain medication regimen changes will be assessed for patients who were taking an opioid metabolized primarily by CYP2D6. Pain medication regimen changes from baseline to day 45. The timing of subsequent changes in pain regimes after initial opioid selection will also be recorded.	45 days
Hospitalization or Emergency Visit for Pain Control	The rates of hospitalization and emergency room visits for pain are examined with the rates of increased utilization of health care resources, such as emergency department visits, hospitalizations, and pain consultations. Rates of hospitalization or emergency room visits from baseline to day 45.	45 days
Cumulative Morphine Equivalents Required	Cumulative Morphine Equivalents will be defined as total amount of opioids taken by a patient that is converted into its morphine equivalent. Dose and frequency of each opioid given during 45 days after its index prescription will be considered during calculation to give final values, which will be compared to Cumulative Morphine Equivalents for Control arms treated per standard of care.	45 days
Type of First Opioid Prescribed		From enrollment until study end (up to 5 years)

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Human Genome Research Institute (NHGRI)
• Investigators: Principal Investigator: Peter H O'Donnell, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): January 7, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacogenomic; Opioids
• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Genetic Testing; Genetic Techniques; Genetic Services; Diagnostic Services; Pharmacogenomic Testing
• Other Study ID Numbers: IRB24-0700; 1R01HG012273-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No