None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the efficacy of an oral capsule containing plant-derived tetrahydrocannbinol (THC) and cannabidiol (CBD) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with any cancer for which you are scheduled to receive at least three further chemotherapy cycles using intravenous chemotherapy of high or moderate emetic risk. Study details We will first enrol 80 participants in a pilot trial and if the data from these participants shows the medicine works and is well tolerated, a further 170 participants will be enrolled, this is called the definitive trial. Participants enrolled in the pilot trial will be randomly allocated (by chance) to receive the study drug for the first five days of their first chemotherapy cycle following enrolment, followed by a placebo capsule for the first five days of the next chemotherapy cycle, or to receive the placebo first followed by the study treatment. All participants will then choose which treatment they would prefer to take for the first five days of the third chemotherapy cycle. Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. Participants enrolled in the definitive trial will be randomly allocated (by chance) to receive the study drug or the placebo for the first five days of their next three chemotherapy cycles following enrolment, Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. It is hoped that this trial will provide preliminary information on the efficacy of THC and CBD capsules for the prevention of CINV, which will inform further clinical trials.
Interventions
Oral capsule containing 2.5mg THC and 2.5mg CBD, derived from Cannabis Sativa L. Extract, containing Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) in near-equal amounts.
Frequency and duration of administration: taken once the day before chemotherapy and three times daily for 5 days for the first 5 days of participants' chemotherapy cycle and for three consecutive cycles.
Adherence in monitored by counting the returned capsules and comparing with the amount dispensed less the amount
Oral capsule containing 2.5mg THC and 2.5mg CBD, derived from Cannabis Sativa L. Extract, containing Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) in near-equal amounts. Frequency and duration of administration: taken once the day before chemotherapy and three times daily for 5 days for the first 5 days of participants' chemotherapy cycle and for three consecutive cycles. Adherence in monitored by counting the returned capsules and comparing with the amount dispensed less the amount documented to have been ingested by the participant. Participants enrolled in the pilot phase of the study are excluded from enrollment in the definitive phase. In the Phase II part of the study, the first two cycles will be a placebo controlled, randomised crossover design, with the third being decided by participant preference. In the Phase III part of the study will be placebo controlled, randomised parallel design.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
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
1. Adults, aged 18 years and older, with known malignancy of any stage 2. Receiving intravenous chemotherapy of high or moderate emetic risk as defined by MASCC criteria on Treatment Day 1 administered in cycles of planned duration greater than or equal to 14 days and less than or equal to 21 days Note: - Chemotherapy agents classified as low and/or minimal emetic risk may be used concurrently throughout the treatment period (acceptable combination regimens include but not limited to: FOLFOX, carboplatin day 1 and gemcitabine day 1 and 8) - Multi-day use of chemotherapy of high or moderate emetic risk is permitted up until but not beyond day 5 is permitted, when the continuation of the chemotherapy is part of the overall Day 1 regimen (acceptable multi-day regimens include but not limited to: BEP, TIP; unacceptable multi-day regimens include but not limited to: weekly cisplatin, weekly carboplatin, cisplatin day 1 & 8 with gemcitabine day 1 & 8, MVAC) - Concurrent oral chemotherapy and radiotherapy are not permitted 3. Requires greater than or equal to 2 further cycles of chemotherapy 4. Experiencing significant CINV during previous cycle 1 - defined as need for rescue medications for vomiting or distress by nausea, and/or greater than or equal to moderate nausea on 5-point rating scale, despite best-practice MASCC guideline-consistent anti-emetic regimen 5. ECOG performance status of 0, 1 or 2 6. Predicted life expectancy of greater than or equal to 4 months 7. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments including diary, quality of life forms, urine tests, and any mandated blood tests 8. Signed, written informed consent
Exclusion criteria
1. Symptomatic primary or secondary CNS malignancy 2. Symptomatic gastrointestinal obstruction 3. Disease-related nausea or vomiting requiring daily anti-emetic therapy 4. Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, unstable congestive cardiac failure) 5. History of epilepsy or recurrent seizures 6. History of schizophrenia, other psychotic illness, severe personality disorder, suicidal ideation, or other significant psychiatric disorder, other than depression associated with underlying condition 7. Substance use disorder (ICD-10 criteria (abuse, dependence) to alcohol, opioids, benzodiazepines, or illicit stimulants 8. Serious medical or psychiatric condition that might limit the ability of the patient to consent to the study and/or comply with the protocol 9. Scheduled to receive oral chemotherapy during planned duration of study 10. Patient has received or is scheduled to receive radiation therapy to the brain, abdomen or pelvis in the week prior to commencement of study treatment, or during study treatment 11. Is scheduled to receive any investigational drug during the present study 12. Patients using or having used cannabis or cannabinoid based medications within 30 days of study entry and unwilling to abstain for the duration of the study 13. Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications, 5HT3 antagonist, dexamethasone, NK1 antagonist 14. Unwilling to avoid driving or operating machinery during and for 72 hours after taking study medication 15. Concerns regarding safe storage of study medication (eg. unsuitable home environment) 16. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception. 17. Patients who were previously enrolled in this study and received the study intervention (oral THC/CBD and/or placebo) 18. Patients who declare they have been convicted of a criminal offence.
Outcome results
None listed