Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacogenetic testing, Drug-Drug interaction analysis.
- Who it may be relevant to
- Registry conditions: Nausea With Vomiting Chemotherapy-Induced, Depression, Reactive, Cancer Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial
Overview
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.
Interventions
- Genetic Pharmacogenetic testing
Genotyping for CYP2D6 and CYP2C19 - Other Drug-Drug interaction analysis
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
Primary outcome measures
- Drug level measurements [Time frame: Baseline visit to 6 months]
Secondary outcome measures (5)
- Edmonton Symptom Assessment Scale (ESAS) Survey [Time frame: Baseline visit to 6 months]
- Center for Epidemiologic Studies Depression Scale (CES-D) Survey [Time frame: Baseline visit to 6 months]
- Visual Analog Scale (VAS) for pain [Time frame: Baseline visit to 6 months]
- MASCC Antiemesis Tool (MAT) survey [Time frame: Baseline visit to 6 months]
- Antidepressant Side-Effect Checklist (ASEC) [Time frame: Baseline visit to 6 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Lawson Health Research Institute — London
Identifiers
NCT: NCT05830279 · 11642