Adult Patients Who Are Receiving Oncologic Care
Conditions
Keywords
Pharmacogenomic, Opioids
Brief summary
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.
Interventions
OTHERPharmacogenomic (PGx) results.
These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
Sponsors
University of Chicago
National Human Genome Research Institute (NHGRI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain control. | 45 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Medication Regimen Changes | 45 days | 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. |
| Hospitalization or Emergency Visit for Pain Control | 45 days | 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. |
| Cumulative Morphine Equivalents Required | 45 days | 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. |
| Type of First Opioid Prescribed | From enrollment until study end (up to 5 years) | — |
Countries
United States
Contacts
CONTACTClinical Trials Intake
PRINCIPAL_INVESTIGATORPeter H O'Donnell
University of Chicago
Outcome results
None listed