Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nausea With Vomiting Chemotherapy-Induced
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Drug level measurements
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
A prospective longitudinal cohort study that will assess the effect of a Personalized Medicine (PM) clinic recommendations on pharmacogenetic variation and/or interacting drugs on plasma drug exposure, effectiveness or toxicity of commonly used antidepressant, pain, and antiemetic medications in cancer patients. Such recommendations will entail genotype-guided treatment suggestions while also considering potential DDI, and will be provided to patients during their clinic visit, and referring physicians thereafter. Drug concentration and therapeutic effectiveness will be assessed before (baseline) and 6 months after recommendations have been provided. To assess effectiveness, patient-reported outcomes will be evaluated using validated scales for symptoms of depression, pain and chemotherapy-induced nausea/ vomiting
The investigators hypothesize that the pharmacogenetic variation and DDI, if applicable, determine steady state drug concentration and therapeutic response or toxicity of the investigated antidepressant, pain or antiemetic treatments at baseline, while there is a clinically significant reduction or absence of the effect 6 months after the PM clinic recommendations to referring physicians and patients.
Detailed Description
This prospective longitudinal study will consist of three cohorts of adult cancer patients routinely referred to the PM clinic for genotype-guided chemotherapy including 5-FU or tamoxifen that are also taking antidepressant, analgesic and/or antiemetic medications. Patients will be assigned to one or more cohorts, as appropriate, at the screening visit: Cohort 1 (n=200) if prescribed antidepressants including the selective serotonin reuptake inhibitors (SSRI) citalopram or escitalopram, or the selective norepinephrine reuptake inhibitors (SNRI) venlafaxine or desvenlafaxine; Cohort 2 (n=200) if prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol; and/or Cohort 3 (N=200) if prescribed the antiemetic agent ondansetron. Each patient will participate in a PM clinic screening visit. Eligible patients will attend three subsequent study visits at 0.5, 4 (virtual), and 7 months after screening. At each PM clinic visit, clinical information and a venous blood sample will be collected. Patients will also complete the ESAS survey and validated scores/ surveys to evaluate treatment effectiveness.
Investigators
Richard Kim
Professor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Prescribed a chemotherapy medication
- •Currently taking one or more study medications (citalopram, escitalopram, venlafaxine, desvenlafaxine, codeine, oxycodone, hydrocodone, tramadol or ondansetron)
Exclusion Criteria
- •Patients who are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
- •Patients receiving palliative care
- •Patients taking anti-depressants for reason other than depression or anxiety, i.e. hot flash (Only applies to antidepressant cohort)
- •Patients with preexisting major depressive disorder prior to cancer diagnosis (Only applies to antidepressant cohort)
Outcomes
Primary Outcomes
Drug level measurements
Time Frame: Baseline visit to 6 months
Steady-state drug plasma concentration of the antidepressant (Cohort 1), pain (Cohort 2) or antiemetic medication (Cohort 3) at follow-up visit 2 at 6 months compared to the baseline visit as assessed by single time points
Secondary Outcomes
- Edmonton Symptom Assessment Scale (ESAS) Survey(Baseline visit to 6 months)
- Center for Epidemiologic Studies Depression Scale (CES-D) Survey(Baseline visit to 6 months)
- Visual Analog Scale (VAS) for pain(Baseline visit to 6 months)
- MASCC Antiemesis Tool (MAT) survey(Baseline visit to 6 months)
- Antidepressant Side-Effect Checklist (ASEC)(Baseline visit to 6 months)