Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pharmacogenetic testing

    Genetic

    Genotyping for CYP2D6 and CYP2C19

  • Drug-Drug interaction analysis

    Other intervention

    Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Anti-depressants2 interventions
Group B: Opioid pain medications2 interventions
Group C: Anti-metics2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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