None listed
Conditions
Brief summary
The main purpose of this study is to determine what dose and frequency of medicinal cannabis is the best to relieve key symptoms in people with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more, have a confirmed diagnosis of advanced cancer, with significant symptoms of severe pain, and/or vomiting, and/or nausea and/or lack of appetite that are poorly controlled by usual treatments, and a predicted life expectancy of more than 3 months and less than 12 months. Study details All participants in the study will be prescribed one of a number of cannabis medicines. The cannabis product will be given in addition to the usual treatments for their advanced cancer symptoms. On the first day of treatment participants will have 5 blood samples collected over 4 hours to measure the levels of cannabis medicines in their blood. They will also complete some online questionnaires about how they feel and be monitored for side effects. Participants will remain enrolled in this trial and receive the cannabis medication prescribed at no cost until they are no longer able to take it or withdraw from the trial. Participants will be asked to complete regular online questionnaires and have a single blood sample taken every few weeks when they see the trial doctor, until they no longer receive the product and/or withdraw from the trial. It is hoped the information collected in this study will guide the use of cannabis medicines to control symptoms in people with advanced cancer.
Interventions
This is an open label study to profile how advanced cancer patients use a range of cannabis medicines for symptom relief via the collection of prospective data on open label product, dose, efficacy, safety, pharmacokinetics and pharmacodynamics to provide preliminary safety, tolerability and efficacy evidence to guide future studies.
Each patient will be prescribed a cannabis medicine from a defined selection of products currently available in Australia that are compliant with TG093 and GMP reg
This is an open label study to profile how advanced cancer patients use a range of cannabis medicines for symptom relief via the collection of prospective data on open label product, dose, efficacy, safety, pharmacokinetics and pharmacodynamics to provide preliminary safety, tolerability and efficacy evidence to guide future studies. Each patient will be prescribed a cannabis medicine from a defined selection of products currently available in Australia that are compliant with TG093 and GMP regulations, manufactured both overseas and within Australia. The choice of study drug will be guided by the patient’s primary index symptoms and at the discretion of the doctor and supply. Treatment will be oral oil liquids, either Delta-9-Tetrahydrocannabinol (THC) or a combination of THC and Cannabidiol (CBD) in near equal amounts. Treatment will be given in addition to the usual medical treatments for advanced cancer and symptoms, including other medicines and radiotherapy. Dosing guidance for this trial is to 'start low, go slow'and start at 2.5mg THC three times a day in cannabis naive patients, and 5 mg THC three times a day in previous users. Dose titration up or downwards will be in consultation with the doctor according to symptom control and reported side effects (measured on CTCAE v5.0). Maximal dosage of 30 mg THC per day, in line with TGA guidance, is advised. Blood samples for pharmacokinetic profiles will be taken at the first assessment to measure THC and CBD levels. Long term exposure of THC and CBD, and adherence to trial product, will be monitored by a single pharmacokinetic blood sample at each follow-up assessment timepoint (1-2 weeks, 6 weeks, 3 months, 6 months, then every 3 months until death or withdrawal). Clinical assessments, along with validated patient reported outcome measures and an electronic patient diary will record outcomes and guide dose. Patients will remain enrolled in this trial and continue to receive the prescribed cannabis medicines until they are no longer able to take it or withdraw from the trial.
Sponsors
Health Administration Corporation acting through the NSW Ministry of Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older. 2. Has provided written Informed Consent for participation in this trial. 3. Confirmed advanced cancer (any) with or without stable disease. 4. Predicted life expectancy of 3 to 12 months at time of consent, as estimated by the study investigator and confirmed by an additional qualified clinician, independent of the trial. 5. Persistent symptoms of anorexia, nausea or refractory pain, which in the investigator’s opinion are not responsive to implementation of standard practice, and who are ineligible or not wishing to be involved in other clinical trials of cannabis medicines. 6. Willing and able, in investigator’s opinion, to comply with all trial requirements, including keeping a patient diary, completing clinical measurement scales and having pharmacokinetic samples collected as per Participant Information Sheet. Note: completion of these trial requirements is essential and intentional non-compliance may cease access to trial product and will be managed on a case-by-case basis. Non-compliance due to declining health is unintentional and it is hoped unintentional noncompliance due to declining health may be minimised through optional proxy completion of patient reported outcomes and patient diary. 7. Available to attend Trial Site for follow up and collection of investigational product. 8. Participants (and/or partners) capable of childbearing are using adequate contraception. Participants are able to continue to receive standard concomitant care and interventions, such as chemotherapy and radiotherapy, and take medications for other conditions as usual in the advanced care population
Exclusion criteria
1. Lack of capacity to consent. 2. Unwilling to keep a Patient Diary, attend follow up appointments, complete clinical measurement scales or have pharmacokinetic samples. 3. History of schizophrenia, other psychotic illness, severe borderline personality disorder, or other significant psychiatric disorder other than depression or anxiety associated with underlying condition. Delirium is an excluded condition. 4. Previous severe adverse event to any cannabinoid product, such as cannabis related psychosis, panic attack, palpitations. 5. A diagnosed substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, cannabis, benzodiazepines, or illicit stimulants. Nicotine and caffeine are excluded. 6. Known allergy to cannabis or other ingredient of cannabis medicine e.g. carrier oil. Note: Prior access to authorised cannabis medicines or current use of illicit cannabis is not an exclusion, unless associated with a serious adverse event (SAE) or substance use disorder as per exclusion criteria above.
Outcome results
None listed