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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: Completed NA study, sponsored by University of Florida.
NCT02664350 is a NA study that has completed, run by University of Florida. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Brief Pain Inventory-Short Form (BPI-SF) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. This is a 10-point scale with 0 being the best possible score, meaning "no pain", and 10 being the worst possible score, meaning "pain as bad as you can imagine".
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 |
What the finished NCT02664350 record still lists
NCT02664350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which CYP2D6 is the first listed.
NCT02664350 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02664350's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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