Clinical trial NCT05830279: Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer
Official title: Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nausea With Vomiting Chemotherapy-Induced
Depression, Reactive
Cancer Pain
Keywords: Personalized medicine
Pharmacogenetics
Therapeutic drug monitoring
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients taking selective medications for treatment of chemotherapy side effects, pain, depression and nausea.

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.

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)

Primary outcomes:
measure: Drug level measurements
timeFrame: Baseline visit to 6 months
Secondary outcomes:
measure: Edmonton Symptom Assessment Scale (ESAS) Survey
timeFrame: Baseline visit to 6 months
measure: Center for Epidemiologic Studies Depression Scale (CES-D) Survey
timeFrame: Baseline visit to 6 months
measure: Visual Analog Scale (VAS) for pain
timeFrame: Baseline visit to 6 months
measure: MASCC Antiemesis Tool (MAT) survey
timeFrame: Baseline visit to 6 months
measure: Antidepressant Side-Effect Checklist (ASEC)
timeFrame: Baseline visit to 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Richard Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: