None listed
Conditions
Brief summary
This study is investigating the safety and efficacy of cannabis in relieving distressing symptoms of advanced cancer. Who is it for? You may be eligible for this study if you are an adult with advanced histologically proven cancer (metastatic or locally advanced) and have been evaluated by a physician for suitability to join this study. Study details Participants will be randomly allocated to either take a combination of the two main components of cannabis, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in standard doses as an oral solution, or a placebo. Participants will be asked to complete simple ratings to measure symptom burden and quality of life for up to 28 days of the trial. It is hoped that data from this trial will inform the efficacy of cannabis to manage patient distress caused by cancer-related symptoms.
Interventions
Arm 1 – THC/CBD (Delta-9-tetrahydrocannabinol/cannabidiol) 10mg/200mg/mL oral solution (dose range 2.5mg/50mg-30mg/600mg/day)
Dosing commences as per the dosing schedule at 0.25mls daily, increasing every 2 days for 14 days reaching a max dose of 1ml three times per day. The day 14 dose can then be continues for days 15-28. If the participant experiences unwanted adverse effects the dose can be reduced back to the previously tolerated level. The dose can also be stabilised when effectiveness is
Arm 1 – THC/CBD (Delta-9-tetrahydrocannabinol/cannabidiol) 10mg/200mg/mL oral solution (dose range 2.5mg/50mg-30mg/600mg/day) Dosing commences as per the dosing schedule at 0.25mls daily, increasing every 2 days for 14 days reaching a max dose of 1ml three times per day. The day 14 dose can then be continues for days 15-28. If the participant experiences unwanted adverse effects the dose can be reduced back to the previously tolerated level. The dose can also be stabilised when effectiveness is reached prior to day 14 if applicable. Study drug must be brought in to each study visit to monitor compliance.
Sponsors
Mater Misericordiae Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 of 10 of higher for cancer-related symptoms*, and at least one individual ESAS score of 3 or higher (for sleep component need to have a sleep NRS score of 3 or higher) -a Performance Status AKPS (Australia-modified Karnofsky Scale score) of at least 30 -are aged 18 years or older, English-speaking (or have an 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 at eligibility for previous cannabinoid use -are able to tolerate oral medications -are willing to receive standard palliative care as delivered by their primary treating team -can comply with all trial requirements: agree to attend scheduled clinic appointments, adhere to dose titration schedules as directed -agree to use no other cannabis based products for the duration of the trial -understand that 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. • are able to provide fully informed consent * physician assessed
Exclusion criteria
Patients with: -a history of hypersensitivity to any cannabinoid -unstable, untreated cardiovascular disease (hypertension, ischaemic heart disease, congestive cardiac failure) -severe hepatic impairment (total bilirubin of 1.5 times or greater than the upper limit of the institution’s normal range, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 3.0 times or greater than the upper limit of the institution’s normal range. Subjects with liver metastasis may have an AST and ALT of up to 5.0 times the upper limit of normal) -severe renal impairment (eGFR of 20mL/min/1.73m2 or greater) -known allergy to nuts, coconut, avocado, sage or rosemary -a history of psychosis, schizophrenia or severe mood disorders -cognitive impairment (SLUMS - St Louis University Mental Status) examination equal to or less than 20/30. -known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening Test) examination scoring greater than 27 for any substance -history suggesting that drug diversion may be a risk for them or their family/carers -females who are pregnant or lactating -concurrent or participation in a trial of a new clinical entity within the last 28 days -treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or radiation within the last 7 days
Outcome results
None listed