CannabisCINV: A placebo-controlled trial evaluating an oral THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting in patients of any known malignancy receiving chemotherapy.
- Conditions
- Chemotherapy induced nausea and vomitingCancerCancer - Any cancer
- Registration Number
- ACTRN12616001036404
- Lead Sponsor
- niversity of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 151
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to compare, amongst patients randomised to oral THC/CBD or placebo, the compositie outcome of the ability to control emesis and nausea. This will be assessed using patient reported outcomes recorded in a diary daily for the 6 days of study treatment through each of the three chemotherapy cycles and the completion of the Functional Living Index - Emesis 5 day questionnaire at the end of each cycle.[ Daily for the 6 days of study treatment through each of the three chemotherapy cycles.]
- Secondary Outcome Measures
Name Time Method