A study that evaluates the effectiveness of oral combined THC/CBD for people with advanced cancer experiencing a range of symptoms.
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 Limited
144 participants
Sep 9, 2019
Interventional
Conditions
Summary
The purpose of this study is to assess whether delta-9-tetrahydrocannabinol (THC) and cannabidoil (CBD) can be used to reduce total symptoms in patients with advanced cancer in palliative care. Who is it for? You may be eligible for this study if you are over 25 years of age and have been diagnosed with advanced cancer. Study details Participants will be randomly assigned to one of two treatment groups; either THC/CBD or a placebo medication. Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. During the 28 days of the study you will be required to have routine bloods and urine test which will be used as part of the eligibility and post trial analysis It is hoped that this research will show a positive effect of THC/CBD on symptoms for patients suffering with advanced cancer and thus provide an option in helping manage symptoms.
Eligibility
Inclusion Criteria20
- 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
Exclusion Criteria19
- 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
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Interventions
Patients with advanced cancer will participate in a double-blind, placebo controlled, and randomisation clinical trial. Each participant will follow a dose titration schedule for 14 days and a follow on stable dose for a further 14 days. Participants will be allocated into a treatment arm according to a block randomisation schedule held by a central registry. There will be one active arm (THC/CBD) and an inert oral oily liquid (placebo). Concentration of medication: THC/CBD (delta-9-tetrahydrocannabinol)/(cannabidiol) 10mg/mL oral oily liquid (dose range 2.5mg/2.5mg - 30mg/30mg/day) Dosing schedule: Dose titration (days 0 - 14) will be confirmed by the treated doctor with doses starting at: Days 0 & 1 – 1 dose/day = total daily dose 2.5mg/2.5mg (0.25mL) Day 2 & 3 – 1 dose/day = total daily dose 5mg/5mg (0.5mL) Day 4 & 5 – 2 dose/day = total daily dose 10mg/10mg (1mL) Day 6 & 7 – 3 doses/day = total daily dose 15mg/15mg (1.5mL) Day 8 & 9 – 3 doses/day = total daily dose 20mg/20mg (2mL) Day 10 & 11 – 3 doses/day = total daily dose 25mg/25mg (2.5mL) Day 12 & 13 – 3 doses/day = total daily dose 30mg/30mg (3mL) Day 14 – 28 – Continue on final dose reached Each participant will be advised to increase their dose according to the dosing schedule until they are satisfied with symptom improvement and no unacceptable side effects (according to the CTCAE graded >4 (confusion, somnolence, personality change, paranoia, anxiety, mood change, psychosis, hypertension, tachycardia, sweating, nausea, vomiting, abdominal pain). The patient then will be given the option of remaining on the cannabinoid preparation for continuing assessment of efficacy and adverse events for a further 14 days totaling 28 days on the study drug. Patients will have the choice of lowering their dose according to symptom improvement. Dose titration downwards will be in consultation with the doctor. Participants will be required to return empty/unused bottles each clinic visit to receive a further supply.
Locations(6)
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ACTRN12619000037101