Nausea With Vomiting Chemotherapy-InducedNCT05830279
Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer
An observational study of Nausea With Vomiting Chemotherapy-Induced and Depression, Reactive, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea With Vomiting Chemotherapy-Induced, Depression, Reactive, Cancer Pain
- What is being tested?
- Pharmacogenetic testing and Drug-Drug interaction analysis
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2023to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients taking selective medications for treatment of chemotherapy side effects, pain, depression and nausea.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Lawson Health Research Institute
London, Ontario, N6C 2R5
About this study
Official title: Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal 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.
Read the 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.
- Being tested
- Pharmacogenetic testing, Drug-Drug interaction analysis
- Keywords
- Personalized medicine, Pharmacogenetics, Therapeutic drug monitoring
- Medical subject headings
- Adjustment Disorders, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic testingGenetic
Genotyping for CYP2D6 and CYP2C19
Drug-Drug interaction analysisOther
Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.
| Study group | Role | What they receive |
|---|---|---|
| Anti-depressants | Patients who have been prescribed either 1) the selective serotonin reuptake inhibitors (SSRI) citalopram or escitalopram, or 2) the selective norepinephrine reuptake inhibitors (SNRI) venlafaxine or desvenlafaxine Receives: Genetic: Pharmacogenetic testing; Other: Drug-Drug interaction analysis | |
| Opioid pain medications | Patients who have been prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol. Receives: Genetic: Pharmacogenetic testing; Other: Drug-Drug interaction analysis | |
| Anti-metics | Patients who have been prescribed the antiemetic agent ondansetron Receives: Genetic: Pharmacogenetic testing; Other: Drug-Drug interaction analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline visit to 6 months
Secondary outcomes (5)
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.
Measured: Baseline visit to 6 months
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.
Measured: Baseline visit to 6 months
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.
Measured: Baseline visit to 6 months
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
Measured: Baseline visit to 6 months
Antidepressant Side-Effect Checklist (ASEC)
Difference in ASEC score in each cohort at the follow up visits (3 and 6 months) compared to baseline visit. 21 questions, scale for each question between 0-3, higher score is associated with worse outcomes.
Measured: Baseline visit to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 May 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea With Vomiting Chemotherapy-InducedStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Kim, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Richard Kim, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830279
- Sponsor's protocol ID
- 11642
- Status last verified
- Jul 2025
- First submitted
- 13 Apr 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial
- ClinicalTrials.gov ID
- NCT05830279
- Acronym / sponsor ID
- 11642
- Keywords
- Personalized medicine, Pharmacogenetics, Therapeutic drug monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-depressants | – | Genetic: Pharmacogenetic testing, Other: Drug-Drug interaction analysisPatients who have been prescribed either 1) the selective serotonin reuptake inhibitors (SSRI) citalopram or escitalopram, or 2) the selective norepinephrine reuptake inhibitors (SNRI) venlafaxine or desvenlafaxine |
| Opioid pain medications | – | Genetic: Pharmacogenetic testing, Other: Drug-Drug interaction analysisPatients who have been prescribed opioid pain medications including codeine, oxycodone, hydrocodone, or tramadol. |
| Anti-metics | – | Genetic: Pharmacogenetic testing, Other: Drug-Drug interaction analysisPatients who have been prescribed the antiemetic agent ondansetron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients taking selective medications for treatment of chemotherapy side effects, pain, depression and nausea.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic testingGenotyping for CYP2D6 and CYP2C19 | Genetic | Anti-depressants, Anti-metics, Opioid pain medications |
| Drug-Drug interaction analysisEvaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter. | Other | Anti-depressants, Anti-metics, Opioid pain medications |
Primary outcome
Drug level measurements
Time frame: Baseline visit to 6 months
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Kim, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea With Vomiting Chemotherapy-Induced and Depression, Reactive, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Kim, MD (519-685-8500 ext. 33553, richard.kim@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug level measurements (time frame: Baseline visit to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.