About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
Cancer patients taking selective medications for treatment of chemotherapy side effects, pain, depression and nausea.
Trial design
Cohort
Prospective
Treatments tested in this trial
Pharmacogenetic testing
GeneticGenotyping for CYP2D6 and CYP2C19
Drug-Drug interaction analysis
Other interventionEvaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
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.
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
Sponsors and contacts
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