Меню
Идёт набор NCT06266611

Cannabis for Palliative Care in Cancer

Фаза II С лечением Sleep Anxiety Depression 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: fsCBD Cannabidiol, Placebo, bsCBD Cannabidiol.
Кому может быть актуально
Состояния в реестре: Sleep, Anxiety, Depression, Pain. Базовые параметры: от 25 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC

Обзор

Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.

Вмешательства

  • Препарат fsCBD Cannabidiol
    Full Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
  • Препарат Placebo
    Placebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
  • Препарат bsCBD Cannabidiol
    Broad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used

Первичные конечные точки

  • Pain Interference [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Pain Intensity [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Pain Inventory [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Sleep Disturbance [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Sleep-Related Impairment [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Depression/Anxiety [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Fatigue [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Health Related Quality of Life [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • FACT-Cog Cognitive Function [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Stroop Task Test of Cognitive Function [Срок оценки: Baseline, 4 weeks, 8 weeks]
Вторичные конечные точки (3)
  • Polypharmacy for Pain [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Polypharmacy for Psychiatric Rx [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Polypharmacy for Sleep [Срок оценки: Baseline, 4 weeks, 8 weeks]

Критерии участия

Критерии включения

  • Able to provide informed consent
  • Aged ≥25 years at Visit 1 (Baseline)
  • Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months
  • Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
  • Desire to use cannabis to treat their symptoms
  • Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months
  • Willing to practice acceptable methods of birth control until completing study medication

Критерии исключения

  • Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
  • Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
  • Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
  • Current use of anti-psychotic medications
  • Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone)
  • Liver function tests (Alanine transaminase \[ALT\] and Aspartate transaminase \[AST\]) levels ≥2x the upper normal limits
  • Moderate or severe liver disease
  • Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia
  • History of seizures
  • For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy
  • Physician response to passive consent indicating contraindications for participation.
  • Unwilling to refrain from cannabis use other than study drug for the entire study duration
  • Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Anschutz Health Sciences Building — Aurora

Идентификаторы

NCT: NCT06266611 · 23-0982

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗