None listed
Conditions
Brief summary
Recently there has been a growing interest in the use of cannabis to try and relieve symptoms of pain, nausea, shortness of breath, anxiety, and depression, in patients with advanced cancer. The purpose of this study is to determine an appropriate dosing regimen, safety and efficacy for THC and CBD (both components of cannabis) for symptom relief in patients with advanced cancer. Who is it for? You may be eligible for this study if you are over the age of 25 and have been diagnosed with advanced cancer. Study details Participants will be allocated into 1 of 2 treatment arms. Group 1 will be receiving CBD (cannabidoil) and Group 2 will be receiving THC (Delta-9-Tetrahydrocannabinol). Determination of the treatment given to the participant will be based on the participant, the treating doctor, and the supply of the 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. Participants will be required to have a blood test and if any females are of child bearing potential a urine test to determine eligibility. It is hoped that this research will be effective in determining a safe and effective dose for symptom relief in patients with advanced cancer.
Interventions
This study is a prospective, two-arm, open label trial of escalating doses of Cannabidiol (CBD) and Delta-9-Tetrahydrocannabinol (THC). The choice of the study drug will be at the discretion of the patient, doctor and dependent on supply. Each patient will follow a dose titration schedule for 14 days and a follow on stable dose for a further 14 days.
Concentration of medication:
Arm 1: CBD (Cannabidiol 100mg/ml) oral oily liquid
Arm 2: THC (Delta-9-Tetrahydrocannabinol 10mg/ml) oral oily liqui
This study is a prospective, two-arm, open label trial of escalating doses of Cannabidiol (CBD) and Delta-9-Tetrahydrocannabinol (THC). The choice of the study drug will be at the discretion of the patient, doctor and dependent on supply. Each patient will follow a dose titration schedule for 14 days and a follow on stable dose for a further 14 days. Concentration of medication: Arm 1: CBD (Cannabidiol 100mg/ml) oral oily liquid Arm 2: THC (Delta-9-Tetrahydrocannabinol 10mg/ml) oral oily liquid Dosing schedule Dose titration (days 0 – 14) will be confirmed by the treating doctor with doses starting at: Arm 1 Days 0 & 1 – 1 dose/day = total daily dose 50mg (0.5ml) Day 2 & 3 – 1 dose/day = total daily dose 100mg (1ml) Day 4 & 5 – 2 dose/day = total daily dose 200mg (2ml) Day 6 & 7 – 3 doses/day = total daily dose 300mg (3ml) Day 8 & 9 – 3 doses/day = total daily dose 400mg (4ml) Day 10 & 11 – 3 doses/day = total daily dose 500mg (5ml) Day 12 & 13 – 3 doses/day = total daily dose 600mg (6ml) Day 14 – 28 – Continue on final dose reached Arm 2 Days 0 & 1 – 1 dose/day = total daily dose 2.5mg (0.25ml) Day 2 & 3 – 1 dose/day = total daily dose 5mg (0.5ml) Day 4 & 5 – 2 dose/day = total daily dose 10mg (1ml) Day 6 & 7 – 3 doses/day = total daily dose 15mg (1.5ml) Day 8 & 9 – 3 doses/day = total daily dose 20mg (2ml) Day 10 & 11 – 3 doses/day = total daily dose 25mg (2.5ml) Day 12 & 13 – 3 doses/day = total daily dose 30mg (3ml) Day 14 – 28 – Continue on final dose reached Each patient will be advised to increase their dose according to the dosing schedule until they are satisfied with their symptom improvement and there are no unacceptable side effects (according to CTCAE graded >4). The patient then will be given the option of remaining on the cannabinoid preparation for continuing assessment of efficacy and adverse events for a total of 28days. Patients will have the choice of lowering their dose according to symptom improvement. Dose titration downwards will be in consultation with the doctor.
Sponsors
The University Of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with advanced histologically proven cancer (metastatic or locally advanced solid tumours or advanced haematological malignancies) who have been referred or known to the palliative care team who: - have an ESAS TSDS >10 - at lease one individual ESAS score >3 - AKPS score >30 - aged >25yrs. English speaking (or interpreted available), give fully informed consent - 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 - able to tolerate oral medication and comply with trial requirements - agree to use no other cannabis based product - understand it is illegal to drive a motor vehicle
Exclusion criteria
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 Alanine aminotransferase (ALT) >3.0 time the upper limit. Subjects with liver metastasis may have an AST and ALT >5.0 time the upper limit - 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+; historyof drug diversion may be a risk for them or their family/carers - females who are pregnant or lactating - participation in a trial of a new clinical entity with the last 28 days - treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) within the last 21 days or radioation within the last 7 days
Outcome results
None listed