An observational study in Nausea With Vomiting Chemotherapy-Induced, Depression, Reactive and Cancer Pain, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Observational
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.
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.
Cancer patients taking selective medications for treatment of chemotherapy side effects, pain, depression and nausea.
Exclusion Criteria:
Patients who have been prescribed either 1) the selective serotonin reuptake inhibitors (SSRI) citalopram or escitalopram, or 2) the selective norepinephrine reuptake inhibitors (SNRI) venlafaxine or desvenlafaxine
Genetic: Pharmacogenetic testing · Other: Drug-Drug interaction analysis
Patients who have been prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol.
Genetic: Pharmacogenetic testing · Other: Drug-Drug interaction analysis
Patients who have been prescribed the antiemetic agent ondansetron
Genetic: Pharmacogenetic testing · Other: Drug-Drug interaction analysis
Genotyping for CYP2D6 and CYP2C19
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Drug level measurements
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
Time frame: Baseline visit to 6 months
Edmonton Symptom Assessment Scale (ESAS) Survey
Difference in ESAS survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. 10 questions, scale for each question between 0-9, higher score is associated with worse outcomes.
Time frame: Baseline visit to 6 months
Center for Epidemiologic Studies Depression Scale (CES-D) Survey
Difference in CES-D survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. 20 questions, scale for each question between 0-3, higher score is associated with worse outcomes.
Time frame: Baseline visit to 6 months
Visual Analog Scale (VAS) for pain
Difference in VAS Pain score in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. Scale 0-100, higher score is associated with worse outcomes.
Time frame: Baseline visit to 6 months
MASCC Antiemesis Tool (MAT) survey
Difference in MAT survey results in each cohort at the follow up visits (3 and 6 months) compared to baseline visit
Time frame: Baseline visit to 6 months
Antidepressant Side-Effect Checklist (ASEC)
Difference in ASEC score in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. 21 questions, scale for each question between 0-3, higher score is associated with worse outcomes.
Time frame: Baseline visit to 6 months
Plan to share: No
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's