Precision Medicine Guided Treatment for Cancer Pain
Completed · Not applicable
Conditions studied: Pain, CYP2D6 Polymorphism
In brief
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.
Key facts
- Study ID
- NCT02664350
- Run by
- University of Florida
- People needed
- 63
- Starts
- 2016-04-01
- Expected to finish
- 2019-01-10
- Last updated by the study team
- 2019-01-14
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of histologically or cytologically proven solid tumor with or without metastasis
- Receiving treatment at UF Health Cancer Center for outpatient pain management with an opioid
You may not qualify if…
- Undergone surgery within the last three months or are scheduled to undergo surgery during the study period (4 weeks)
- Documented psychiatric or neurological condition that would interfere with study participation
- Liver transplant
- Allergic to opioids
Where it is running
- University of Florida — Gainesville, Florida, United States
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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