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Идёт набор NCT05754840

CANnabinoids in Pediatric ONCology

Фаза I / Фаза II С лечением Childhood Cancer Cancer

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: MPL-001, MPL-005, MPL-009.
Кому может быть актуально
Состояния в реестре: Childhood Cancer, Cancer. Базовые параметры: 4 лет — 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial

Обзор

CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.

Подробное описание

This is a multi-centered, pragmatic, double-blind, adaptive, dose-escalation study to establish the tolerability of Cannabis Herbal Extracts (CHE) containing different ratios of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Study arms will contain the following ratios THC:CBD 1:25 (arm 1), 1:5 (arm 2) and 1:1 (arm 3). CAN-PONC will enroll 20 participants recruited into each arm, for a total of 60 study participants.

To inform the dose for the arm containing the most THC, this study will take place in two stages. In Stage One: The first 20 participants will be randomized 1:1 into arm 1 and arm 2. Once 20 participants have been recruited, trial recruitment will halt until the last participant reaches the maintenance phase, the maximum THC dose at which less than 30% of participants reported dose limiting toxicities (Max-D30) has been established, the remaining 40 recruited participants will be randomized 1:1:2 into arm 1, arm 2 and arm 3 in Stage Two of this study.

All arms consist of three phases: baseline phase (no interventional product for two weeks), treatment phase (dose escalations for eight weeks), and a maintenance phase (maximum tolerated dose for four weeks).

Вмешательства

  • Препарат MPL-001
    High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. The MPL-001 oil is produced by MediPharm Labs, each ml contains 50mg CBD and 2mg THC.
  • Препарат MPL-005
    Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. The MPL-005 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 5mg THC.
  • Препарат MPL-009
    Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. The MPL-009 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 25mg THC.

Первичные конечные точки

  • Incidence of adverse events (Tolerability) [Срок оценки: 14 weeks]
Вторичные конечные точки (4)
  • Pain intensity [Срок оценки: daily for 14 weeks]
  • Symptom burden [Срок оценки: 3 times per week for 14 weeks]
  • Quality of life (child) [Срок оценки: once per week for 14 weeks]
  • Sleep (hours per night) [Срок оценки: daily for 14 weeks]

Критерии участия

Критерии включения

  • Ages 4-17 years old at the time of enrollment
  • Diagnosed with relapsed or refractory solid or hematologic malignancy including brain tumours
  • Currently receiving active cancer treatment or supportive and palliative care
  • Estimated survival of at least 4 months at the time of enrollment

Критерии исключения

  • History of cardiovascular disease, severe hepatic or renal impairment defined by alanine transaminase (ALT)/ aspartate aminotransferase (AST) more than 5x upper limit of normal (ULN), creatinine more than 5x ULN or glomerular filtration rate (GFR less than) <60 mL/min/1.73 m273m2, unstable/unmanaged arrhythmias, uncontrolled hypertension with blood pressure above 99th centile for age or history of myocardial infarction
  • Nabilone or other cannabis-based products use (including for recreational purposes) within the past 2 weeks or planned nabilone use for the duration of their enrollment in the trial. Current use/continued use of recreational cannabis, or not willing to abstain from recreational cannabis use during the trial
  • Anyone who is pregnant or breast/chest-feeding throughout the duration of the study or has the intention to become pregnant within 3 months of study completion
  • Participation in other clinical trials that prohibit the concurrent use of cannabis
  • Children with a personal or family history of schizophrenia or psychotic disorders, substance use disorder or allergy to cannabinoids or cannabis
  • Unwilling or unable to use effective form of contraception and refrain from driving motorized vehicles (cars, motorcycles, boats, etc.) throughout the study period
  • Anyone who is currently receiving cell therapies or immune checkpoint inhibitors

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 3 центра
  • BC Children's Hospital — Vancouver
  • IWK Health Centre — Halifax
  • The Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT05754840 · CAN-PONC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗