A phase I/II double-blind, randomised controlled trial assessing effect of medicinal cannabis on quality of life and symptom control in advanced cancer.
- Conditions
- Advanced CancerPalliative CareCancer - Any cancer
- Registration Number
- ACTRN12619001534178
- Lead Sponsor
- Olivia Newton-John Cancer Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 119
*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.
1.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
2.Having current radiotherapy, completed radiotherapy <14 days prior to first day of study therapy, or planning to have radiotherapy in the next 30 days
3.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
4.Conditions preventing adequate absorption of study drug (including difficulty swallowing medications, intestinal obstruction, inflammatory bowel condition, colitis)
5.Inadequate renal function, defined as eGFR <30ml/min (using CKD-EPI calculation)
6.Substance use disorder (ICD-10 criteria (abuse, dependence) to alcohol, opioids, benzodiazepines, or illicit stimulants
7.Current or recent use of cannabis within 30 days prior to study entry. Participants must return a negative cannabis urine test.
8.Prior clinically significant adverse reaction to cannabis or cannabinoid based medications.
9.Unwilling to avoid driving or operating machinery whilst on trial.
10.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).
11.Psychiatric or neurodegenerative condition which in the opinion of the investigator may compromise patient safety.
12.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.
13.Actively receiving a concurrent investigational product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1 Primary Outcome (composite):<br>To determine the safety, tolerability, and dose range of the study drug by evaluating and characterising the pharmacokinetic profile of medicinal cannabis and active metabolites, analysis of dose-limiting toxicities, and adverse events. <br>Pharmacokinetic parameters being assessed include serum concentration of CBD002 and metabolites. <br>Dose-limiting toxicities and adverse events will be measured by CTCAE criteria which can be classified by clinical examination, laboratory findings or patient reported symptoms. [ Baseline (pre-dose), and 1, 2, 4, and 8 hours post administration of study drug, done on Days 1, 8, 15, and 29 post initiation of Medicinal Cannabis/Placebo.<br>];Phase 2 Primary Outcome:<br>To determine the impact of medicinal cannabis on global quality of life, as measured by change in EORTC QLQ PAL-Q30 from baseline. <br>[ Day 29 post initiation of Medicinal Cannabis/Placebo.<br>]
- Secondary Outcome Measures
Name Time Method