Oral Medicinal cannabinoids to Relieve Symptom Burden in the Palliative care of Patients with Advanced cancer: a double-blind, placebo controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

Mater Misericordiae Limited0 个研究点目标入组 144 人开始时间: 2019年1月14日最近更新: 2024年4月15日

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•Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:
•- have an ESAS TSDS greater than 10 for cancer-related symptoms*
•- at least one individual ESAS score greater than 3
•- AKPS score >30
•- aged >25yrs and above. English speaking (or have interpreter available)
•- have a negative pregnancy urine test at eligibility (only if of reproductive potential) and
•agree to avoid pregnancy during the study and 12 weeks following the last dose of the
•study drug. Males must agree to avoid fathering a child and to not donate sperm during
•the study and for at least 12 weeks following the last dose of the study drug
•- have a negative THC urine test
•- able to tolerate oral medication
•- willing to receive standard palliative care
•- comply with trial requirements; agree to attend scheduled clinic appointments, adhere to dose
•titration schedule as directed
•- agree to use no other cannabis based products for the duration of the trial
•- understand it is illegal to drive whilst taking THC containing cannabis products, to take
•cannabinoid products outside of Australia or to endorse legal documents whilst taking THC
•containing cannabis products
•- provide fully informed consent
•*physician assessed

•Patients with:
•- a history of hypersensitivity to any cannabinoid product
•- unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive
•cardiac failure)
•- severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal
•range. Asparate aminotransferase (AST), and alanne aminotransferase (ALT) >3.0 time the upper
•limit of the institution's normal range; subjects with liver metastasis may have an AST and ALT of
•>5.0 times the upper limit of normal
•- severe renal impairment (eGFR <20mls/min/1.73m2)
•- history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis,
•schizophrenia, first degree relative with schizophrenia and/or suicidal ideation)
•- cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30
•- known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening
•Test) examination score >27+
•- history that drug diversion may be a risk for them or their family/carers
•- females who are pregnant or lactating
•- concurrent or participation of a new clinical entity with the last 28 days
•- treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or
•radiation within the last 7 days

发起方

Mater Misericordiae Limited