A phase I/II double-blind, randomised controlled trial assessing effect of medicinal cannabis on quality of life and symptom control in advanced cancer.
Olivia Newton-John Cancer Research Institute
119 participants
Sep 25, 2020
Interventional
Conditions
Summary
The purpose of this study is to test the impact of medicinal cannabis on quality of life and symptoms in people with advanced cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have advanced cancer and a life expectancy of at least 2 months. Study details Two-thirds of the participants in this study will receive medicinal cannabis, while the other one-third will receive placebo. Both are oils taken by mouth, initially once a day, then increasing to a maximum of 3 times a day. The dose will be increased until symptoms are adequately controlled, then maintained for up to one month. After the trial period is completed, participants will be able to access medicinal cannabis via compassionate access. All participants will provide blood samples and answer questionnaires. We would also like your carer to be involved, if you have one. It is hoped this preliminary study will provide useful information about the risks and benefits of this formulation of medicinal cannabis, and how cannabis is metabolised by the body.
Eligibility
Inclusion Criteria6
- Able to provide written informed consent and greater than or equal to 18 years of age.
- Willing and able to comply with all study requirements, including treatment, blood sampling and other assessments.
- Patients with incurable advanced cancer, of any histological subtype.
- Life expectancy greater than 2 months.
- ECOG 0-2
- Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication and use a medically acceptable form of contraception.
Exclusion Criteria18
- Patients with recent change to systemic anticancer treatment (chemotherapy, immunotherapy, targeted therapy, hormonal therapy). The following time intervals are relative to the first day of study therapy:
- Commenced new anticancer treatment within the last 14 days
- Completed anticancer treatment <14 days ago
- Planning to receive new anticancer treatment in the next 30 days
- Having current radiotherapy, completed radiotherapy <14 days prior to first day of study therapy, or planning to have radiotherapy in the next 30 days
- Severe hepatic impairment, as defined by:
- aspartate aminotransferase (AST) >5 times upper limit of normal, or
- alanine aminotransferase (ALT) >5 times upper limit of normal
- Conditions preventing adequate absorption of study drug (including difficulty swallowing medications, intestinal obstruction, inflammatory bowel condition, colitis)
- Inadequate renal function, defined as eGFR <30ml/min (using CKD-EPI calculation)
- Substance use disorder (ICD-10 criteria (abuse, dependence) to alcohol, opioids, benzodiazepines, or illicit stimulants
- Current or recent use of cannabis within 30 days prior to study entry. Participants must return a negative cannabis urine test.
- Prior clinically significant adverse reaction to cannabis or cannabinoid based medications.
- Unwilling to avoid driving or operating machinery whilst on trial.
- Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications. Patients on strong CYP3A4 inducers or inhibitors, or on strong CYP2C19 inducers or inhibitors (refer to Appendix 3).
- Psychiatric or neurodegenerative condition which in the opinion of the investigator may compromise patient safety.
- Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a highly effective and reliable means of contraception. Male participants must have been surgically sterilised or use a (double if required) barrier method of contraception.
- Actively receiving a concurrent investigational product.
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Interventions
This is a combined Phase 1/2 study. Phase 1 (confirmation of dose finding and participation up to 56 days (up to 28 days screening and 28 days of investigational product administration)) was completed in 2020. Phase 2 is addressing the primary endpoint and will last up to 85 days (up to 28 days' screening, 29 days of investigational product, End of Trial review 28 days after last dose of investigational product). The Investigational Product is an oral liquid (oil) formulation of Medicinal Cannabis or Placebo, with doses between 0.25 mL and 1mL administered one to three times per day, administered orally via syringe, for a maximum of 29 days/1 month. The dose is commenced at 0.25mL once a day, and up-titrated daily based on symptom control and tolerance to a maximum daily dose of 1mL three times a day. Participants increase their dose by 0.25mL at each interval (e.g. morning/afternoon/evening) for symptom control. This is based on their own tolerability of the IP.
Locations(5)
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ACTRN12619001534178