Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Precision Medicine Guided Treatment for Cancer Pain
Brief 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.


Options:
A: Arm Label: Oxycodone Hydrochloride Tablets; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oxycodone | Arm Label: Oxycodone Naloxone Tablets; Type: EXPERIMENTAL; Interventions: Drug: Oxycodone/Naloxone | Intervention Type: DRUG; Name: Oxycodone; Assigned to Arm(s): Oxycodone Hydrochloride Tablets | Intervention Type: DRUG; Name: Oxycodone/Naloxone; Assigned to Arm(s): Oxycodone Naloxone Tablets
B: Arm Label: Morphine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Morphine | Arm Label: Oxycodone; Type: EXPERIMENTAL; Interventions: Drug: Oxycodone | Arm Label: Buprenorphine; Type: EXPERIMENTAL; Interventions: Drug: Buprenorphine | Arm Label: Fentanyl; Type: EXPERIMENTAL; Interventions: Drug: Fentanyl | Intervention Type: DRUG; Name: Morphine; Assigned to Arm(s): Morphine | Intervention Type: DRUG; Name: Fentanyl; Assigned to Arm(s): Fentanyl | Intervention Type: DRUG; Name: Buprenorphine; Assigned to Arm(s): Buprenorphine | Intervention Type: DRUG; Name: Oxycodone; Assigned to Arm(s): Oxycodone
C: Arm Label: Oxycodone Hydrochloride; Type: EXPERIMENTAL; Interventions: Drug: Oxycodone Hydrochloride | Arm Label: Morphine Sulphate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Morphine Sulphate | Intervention Type: DRUG; Name: Oxycodone Hydrochloride; Assigned to Arm(s): Oxycodone Hydrochloride | Intervention Type: DRUG; Name: Morphine Sulphate; Assigned to Arm(s): Morphine Sulphate
D: Arm Label: Genotype Arm; Type: EXPERIMENTAL; Interventions: Genetic: CYP2D6, Behavioral: Brief Pain Inventory-Short Form (BPI-SF), Behavioral: M.D. Anderson Symptom Inventory (MDASI), Genetic: OPRM1 | Arm Label: Traditional Arm; Type: ACTIVE_COMPARATOR; Interventions: Genetic: CYP2D6, Behavioral: Brief Pain Inventory-Short Form (BPI-SF), Behavioral: M.D. Anderson Symptom Inventory (MDASI), Genetic: OPRM1 | Intervention Type: GENETIC; Name: CYP2D6; Assigned to Arm(s): Genotype Arm, Traditional Arm | Intervention Type: BEHAVIORAL; Name: Brief Pain Inventory-Short Form (BPI-SF); Assigned to Arm(s): Genotype Arm, Traditional Arm | Intervention Type: BEHAVIORAL; Name: M.D. Anderson Symptom Inventory (MDASI); Assigned to Arm(s): Genotype Arm, Traditional Arm | Intervention Type: GENETIC; Name: OPRM1; Assigned to Arm(s): Genotype Arm, Traditional Arm

Answer: D