Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This will be a randomized, open label, multi-site clinical trial conducted in UF Health Cancer Center in Gainesville, FL and in Moffitt Cancer Center in Tampa, FL. Each site will be responsible for overseeing patient care and research at their respective facility. This research will examine pain-related outcomes with CYP2D6-guided cancer pain management for study participants. In addition, the investigators will evaluate a prospective cohort study in the same population examining the effect of OPRM1 genetic variants on pain relief and adverse drug effects over time.

Participants will be randomized in a 1:1 manner to receive CYP2D6 genotype-guided (n=50) or non-genotype-guided (traditional, n=50) selection of pain medication. Patients in the genotype arm will be genotyped at baseline for CYP2D6 variants. Participants will fill out the the Brief Pain Inventory-Short Form (BPI-SF) and M.D. Anderson Symptom Inventory (MDASI) questionnaires at baseline. Then, during the clinical visits the same questionnaires will be done during weeks 2, 4, 6, and 8 or by telephone or electronic survey. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02664350
Study type Interventional
Source University of Florida
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date January 10, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care