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Идёт набор NCT05830279

Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer

— Наблюдательное Nausea With Vomiting Chemotherapy-Induced Depression, Reactive Cancer Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pharmacogenetic testing, Drug-Drug interaction analysis.
Кому может быть актуально
Состояния в реестре: Nausea With Vomiting Chemotherapy-Induced, Depression, Reactive, Cancer Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Evaluating the Implementation of Personalized Medicine for Optimal Drug Therapy in Cancer Patients: A Prospective Longitudinal Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Генная терапия Pharmacogenetic testing
    Genotyping for CYP2D6 and CYP2C19
  • Другое Drug-Drug interaction analysis
    Evaluating potential drug interactions with CYP2D6, CYP2C9 and CYP3A4 inhibitors and inducers using the Medical Letter.

Первичные конечные точки

  • Drug level measurements [Срок оценки: Baseline visit to 6 months]
Вторичные конечные точки (5)
  • Edmonton Symptom Assessment Scale (ESAS) Survey [Срок оценки: Baseline visit to 6 months]
  • Center for Epidemiologic Studies Depression Scale (CES-D) Survey [Срок оценки: Baseline visit to 6 months]
  • Visual Analog Scale (VAS) for pain [Срок оценки: Baseline visit to 6 months]
  • MASCC Antiemesis Tool (MAT) survey [Срок оценки: Baseline visit to 6 months]
  • Antidepressant Side-Effect Checklist (ASEC) [Срок оценки: Baseline visit to 6 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Lawson Health Research Institute — London

Идентификаторы

NCT: NCT05830279 · 11642

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗