Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer
Recruiting · NCT05830279 · Observational (researchers observe without assigning treatment) · Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed.
- Lawson Health Research Institute - London, Ontario, Canada