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NCT02664350 · ClinicalTrials.gov registry record · NA
Precision Medicine Guided Treatment for Cancer Pain
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT02664350 is a NA study that has completed, run by University of Florida. The registered enrollment target is 63 participants.
The verdict
NCT02664350, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
Pain is one of the most burdensome symptoms associated with cancer and its treatment, and opioids are the cornerstone of clinical pain management in cancer patients. Yet, individual patient responses to opioids vary widely, and the patient's genotype contributes to this variability. Specifically, cytochrome P450 2D6 (CYP2D6) genotype has important relevance for response to opioid analgesics that depend on CYP2D6 for bioactivation. Poor metabolizers (PMs) have lower concentrations of active metabolites of codeine (morphine), tramadol (O-desmethyltramadol), oxycodone (oxymorphone), and hydrocodone (hydromorphone), compared to extensive metabolizers (EMs). Morphine and O-desmethyltramadol have 200-fold greater affinity for the µ-opioid receptor than the parent compound, whereas oxymorphone and hydromorphone have 40-fold and 10-fold higher receptor affinity compared to their parent compounds, respectively. Consequently, PMs may fail to derive pain relief from these opioids compared to EMs. Interestingly, the occurrence of side effects may not differ between PMs and EMs so that while PMs may get little to no pain relief from certain opioid analgesics, they may still experience troublesome adverse effects. Intermediate metabolizers (IMs) are also expected to have reduced analgesic response based on their significant reduction in enzyme activity. Conversely, individuals with the UM phenotype may have toxic concentrations of active opioid metabolites, with reports of life-threatening toxicity and death. The µ-opioid receptor gene (OPRM1) is the primary binding site for endogenous opioid peptides and opioid analgesics, and may have additional contributions to opioid response. The investigators propose to examine the effect of CYP2D6 genotype-guided pain management on cancer pain control in study participants and the additional effect of the OPRM1 genotype on response to opioids.
Interventions
- GENETIC CYP2D6
- BEHAVIORAL Brief Pain Inventory-Short Form (BPI-SF)
- BEHAVIORAL M.D. Anderson Symptom Inventory (MDASI)
- GENETIC OPRM1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-01-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02664350
The ClinicalTrials.gov registry entry for NCT02664350 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which CYP2D6 is the first listed.
NCT02664350 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02664350 about?
NCT02664350 is a clinical study titled "Precision Medicine Guided Treatment for Cancer Pain". Pain is one of the most burdensome symptoms associated with cancer and its treatment, and opioids are the cornerstone of clinical pain management in cancer patients. Yet, individual patient responses to opioids vary widely, and the patient's genotype contributes to this variability. Specifically, cy...
What is the current status of trial NCT02664350?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2016-04. Estimated completion is 2019-01-10.
What interventions are being tested in trial NCT02664350?
The interventions under investigation include: CYP2D6 (GENETIC), Brief Pain Inventory-Short Form (BPI-SF) (BEHAVIORAL), M.D. Anderson Symptom Inventory (MDASI) (BEHAVIORAL), OPRM1 (GENETIC).
Who is sponsoring clinical trial NCT02664350?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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