Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12619000037101
Ethics application status
Approved
Date submitted
10/01/2019
Date registered
14/01/2019
Date last updated
7/04/2024
Date data sharing statement initially provided
14/01/2019
Date results information initially provided
7/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A study that evaluates the effectiveness of oral combined THC/CBD for people with advanced cancer experiencing a range of symptoms.
Query!
Scientific title
Oral Medicinal cannabinoids to Relieve Symptom Burden in the Palliative care of Patients with Advanced cancer: a double-blind, placebo controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Query!
Secondary ID [1]
297030
0
NIL
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MedCan 2 - THC/CBD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cancer
311007
0
Query!
Fatigue
311008
0
Query!
Nausea
311009
0
Query!
Breathlessness
311010
0
Query!
Appetite
311011
0
Query!
Psychological effects
311012
0
Query!
Condition category
Condition code
Cancer
309658
309658
0
0
Query!
Any cancer
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Patients with advanced cancer will participate in a double-blind, placebo controlled, and randomisation clinical trial. Each participant will follow a dose titration schedule for 14 days and a follow on stable dose for a further 14 days. Participants will be allocated into a treatment arm according to a block randomisation schedule held by a central registry. There will be one active arm (THC/CBD) and an inert oral oily liquid (placebo).
Concentration of medication:
THC/CBD (delta-9-tetrahydrocannabinol)/(cannabidiol) 10mg/mL oral oily liquid (dose range 2.5mg/2.5mg - 30mg/30mg/day)
Dosing schedule:
Dose titration (days 0 - 14) will be confirmed by the treated doctor with doses starting at:
Days 0 & 1 – 1 dose/day = total daily dose 2.5mg/2.5mg (0.25mL)
Day 2 & 3 – 1 dose/day = total daily dose 5mg/5mg (0.5mL)
Day 4 & 5 – 2 dose/day = total daily dose 10mg/10mg (1mL)
Day 6 & 7 – 3 doses/day = total daily dose 15mg/15mg (1.5mL)
Day 8 & 9 – 3 doses/day = total daily dose 20mg/20mg (2mL)
Day 10 & 11 – 3 doses/day = total daily dose 25mg/25mg (2.5mL)
Day 12 & 13 – 3 doses/day = total daily dose 30mg/30mg (3mL)
Day 14 – 28 – Continue on final dose reached
Each participant will be advised to increase their dose according to the dosing schedule until they are satisfied with symptom improvement and no unacceptable side effects (according to the CTCAE graded >4 (confusion, somnolence, personality change, paranoia, anxiety, mood change, psychosis, hypertension, tachycardia, sweating, nausea, vomiting, abdominal pain). The patient then will be given the option of remaining on the cannabinoid preparation for continuing assessment of efficacy and adverse events for a further 14 days totaling 28 days on the study drug.
Patients will have the choice of lowering their dose according to symptom improvement. Dose titration downwards will be in consultation with the doctor.
Participants will be required to return empty/unused bottles each clinic visit to receive a further supply.
Query!
Intervention code [1]
313308
0
Treatment: Drugs
Query!
Comparator / control treatment
The placebo will be an excipient-matched oral oil solution with no active drug in a 50mL bottle
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
318626
0
Change from baseline of total ESAS TSDS
Query!
Assessment method [1]
318626
0
Query!
Timepoint [1]
318626
0
Assessed at baseline and day 14
Query!
Secondary outcome [1]
365535
0
Patient determined effective dose of the 1:1 THC/CBD formulation
Query!
Assessment method [1]
365535
0
Query!
Timepoint [1]
365535
0
Defined as the dose that achieves symptom relief with acceptable side-effects by day 14
Query!
Secondary outcome [2]
365536
0
Combined physical and emotional (pain, tiredness, nausea, shortness of breath, drowsy, appetite, anxiety, depression, wellbeing) will be totalled together at each time point. Each symptom will be rated from 0-10 on the ESAS. Scores will be collected at each time point
Query!
Assessment method [2]
365536
0
Query!
Timepoint [2]
365536
0
Assessed at days 7, 14, 21 and 28
Query!
Secondary outcome [3]
365537
0
Oral morphine equivalent (OME). Conversion of various opioids to an equianalgesic dose of oral morphine (mg/24hr). OME will be assessed by review of medical records. 24hr opioid consumption will be measured as oral morphine equivalents. Opioid conversion e.g. Oxycodone multiplication of a factor 1.5; fentanyl is a multiplication of a factor of 0.3
Query!
Assessment method [3]
365537
0
Query!
Timepoint [3]
365537
0
Average used assessed at baseline and days 7, 14, 21 and day 28
Query!
Secondary outcome [4]
365539
0
Clinical Global Impression (CGI) scales
Query!
Assessment method [4]
365539
0
Query!
Timepoint [4]
365539
0
Assessed at baseline and compared at days 7, 14, 21 and 28
Query!
Secondary outcome [5]
365540
0
DASS-21 score assessing combines depression, anxiety and stress
Query!
Assessment method [5]
365540
0
Query!
Timepoint [5]
365540
0
Assessed at baseline and compared at days 7, 14, 21 and 28
Query!
Secondary outcome [6]
365541
0
Quality of Life using questionnaire EORTC QLQ-C15 PAL
Query!
Assessment method [6]
365541
0
Query!
Timepoint [6]
365541
0
Assessed at baseline and compared at days 7, 14 and 28
Query!
Secondary outcome [7]
365542
0
Adverse Events (AE) recorded using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0) All AE's will be recorded at baseline until end of study (day 28).Particular attention will be given to: mood change, dizziness, somnolence, confusion, concentration, feeling "high" warm/tingle feeling, exaggerated sense of well-being, anxiety, headache, insomnia, clumsiness, lack of coordination, weakness, unsteadiness, red yes, dry mouth, nausea, vomiting, diarrhoea, stomach/abdominal pain, personality change, paranoia, psychosis, hypertension, tachycardia, sweating
Query!
Assessment method [7]
365542
0
Query!
Timepoint [7]
365542
0
Assessed at baseline and compared at days 2, 4, 7, 9, 11, 14, 21 and 28
Query!
Eligibility
Key inclusion criteria
Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:
- have an ESAS TSDS greater than 10 for cancer-related symptoms*
- at least one individual ESAS score greater than 3
- AKPS score >30
- aged >25yrs and above. English speaking (or have interpreter available)
- have a negative pregnancy urine test at eligibility (only if of reproductive potential) and
agree to avoid pregnancy during the study and 12 weeks following the last dose of the
study drug. Males must agree to avoid fathering a child and to not donate sperm during
the study and for at least 12 weeks following the last dose of the study drug
- have a negative THC urine test
- able to tolerate oral medication
- willing to receive standard palliative care
- comply with trial requirements; agree to attend scheduled clinic appointments, adhere to dose
titration schedule as directed
- agree to use no other cannabis based products for the duration of the trial
- understand it is illegal to drive whilst taking THC containing cannabis products, to take
cannabinoid products outside of Australia or to endorse legal documents whilst taking THC
containing cannabis products
- provide fully informed consent
*physician assessed
Query!
Minimum age
25
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patients with:
- a history of hypersensitivity to any cannabinoid product
- unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive
cardiac failure)
- severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal
range. Asparate aminotransferase (AST), and alanne aminotransferase (ALT) >3.0 time the upper
limit of the institution's normal range; subjects with liver metastasis may have an AST and ALT of
>5.0 times the upper limit of normal
- severe renal impairment (eGFR <20mls/min/1.73m2)
- history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis,
schizophrenia, first degree relative with schizophrenia and/or suicidal ideation)
- cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30
- known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening
Test) examination score >27+
- history that drug diversion may be a risk for them or their family/carers
- females who are pregnant or lactating
- concurrent or participation of a new clinical entity with the last 28 days
- treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or
radiation within the last 7 days
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent centre (Mater Research Office) will establish a randomisation schedule. Randomisation will be allocated according to a block randomisation schedule held by the central registry. Block randomisation within each centre will ensure even allocation across each treatment arm. Active and placebo treatments will be labeled and coded by Mater Research Office and will not be revealed to investigators or the participants.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Each participant will complete a 28 day period of treatment, receiving either the active or placebo drug.
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
The sample size is based on previous work by Hui et al., who determined the minimal clinically important difference in the TSDS to be 5.7 (2). As such we have elected to use an improvement of =6 in the TSDS as the primary outcome measure. Allowing 20% for attrition, and with improvement of =6 for CBD compared to placebo, it is anticipated that 144 participants (72 per arm) should be randomized to achieve a sample size of 60 participants per arm, assuming 80% power, a simple random sampling scheme and a Type 1 error of 5% (two-tailed), and a standard deviation of 11.6. The superiority of each medicinal cannabis arm compared to placebo will be tested by comparing the response to each arm after 14 days, relative to baseline.
Descriptive analyses and frequency distributions will be generated from participants’ demographic and clinical characteristics, with all variables explored using graphical methods and summary statistics. In univariate analysis, T tests or the corresponding non-parametric tests (Wilcoxon Rank Sum) will be used to test for differences in change in total symptom distress scores of CBD versus placebo. Generalised estimating equation models with the appropriate link function will be developed to assess the effect of treatment and confounders and/or modifying factors on the primary and secondary outcomes and account for within subject correlation where required. This study is powered to detect superiority of CBD over placebo. If the CBD is shown to be superior to placebo, subsequent studies will need to be undertaken to determine which particular combination (or dose) is superior.
An interim analysis will be performed after one third of the participants have completed 14 days of the trial. The analysis will be performed by a biostatistician blinded for the treatment allocation and reported to the investigators and the DSMB. The purpose of the interim analysis is primarily to monitor and ensure safety of participants rather than evidence of such benefit that early stopping of the trial is justified. AEs and SAEs will be stratified by type and severity. The frequency of AEs and SAEs will be compared between treatment groups using chi-square test and logistic regression if indicated to adjust for any baseline differences between groups.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/04/2019
Query!
Actual
9/09/2019
Query!
Date of last participant enrolment
Anticipated
1/04/2022
Query!
Actual
28/07/2023
Query!
Date of last data collection
Anticipated
31/05/2022
Query!
Actual
19/09/2023
Query!
Sample size
Target
144
Query!
Accrual to date
Query!
Final
144
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
12853
0
Mater Adult Hospital - South Brisbane
Query!
Recruitment hospital [2]
12854
0
Mater Private Hospital - South Brisbane
Query!
Recruitment hospital [3]
12855
0
St Vincent's Hospital Brisbane - Kangaroo Point
Query!
Recruitment hospital [4]
12856
0
Royal Brisbane & Womens Hospital - Herston
Query!
Recruitment hospital [5]
12857
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [6]
12858
0
Gold Coast Hospital - Southport
Query!
Recruitment postcode(s) [1]
25330
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [2]
25331
0
4169 - Kangaroo Point
Query!
Recruitment postcode(s) [3]
25332
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
25333
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [5]
25334
0
4215 - Southport
Query!
Funding & Sponsors
Funding source category [1]
301600
0
Government body
Query!
Name [1]
301600
0
National Health and Medical Research Council (NHMRC)/Medical Research Future Fund (MRFF)
Query!
Address [1]
301600
0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Query!
Country [1]
301600
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Mater Misericordiae Limited
Query!
Address
Mater Misericordiae Ltd
Raymond Terrace
South Brisbane Qld 4101
Query!
Country
Australia
Query!
Secondary sponsor category [1]
301303
0
Hospital
Query!
Name [1]
301303
0
Mater Misericordiae Limited
Query!
Address [1]
301303
0
Mater Misericordiae Ltd
Raymond Terrace
South Brisbane Qld 4101
Query!
Country [1]
301303
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
302326
0
Mater Misericordiae Ltd Human Research Ethics Committee (MML HREC)
Query!
Ethics committee address [1]
302326
0
Raymond Terrace
South Brisbane Qld 4101
Query!
Ethics committee country [1]
302326
0
Australia
Query!
Date submitted for ethics approval [1]
302326
0
29/11/2018
Query!
Approval date [1]
302326
0
14/01/2019
Query!
Ethics approval number [1]
302326
0
HREC/MML/49348
Query!
Summary
Brief summary
The purpose of this study is to assess whether delta-9-tetrahydrocannabinol (THC) and cannabidoil (CBD) can be used to reduce total symptoms in patients with advanced cancer in palliative care.
Who is it for?
You may be eligible for this study if you are over 25 years of age and have been diagnosed with advanced cancer.
Study details
Participants will be randomly assigned to one of two treatment groups; either THC/CBD or a placebo medication.
Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days.
During the 28 days of the study you will be required to have routine bloods and urine test which will be used as part of the eligibility and post trial analysis
It is hoped that this research will show a positive effect of THC/CBD on symptoms for patients suffering with advanced cancer and thus provide an option in helping manage symptoms.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
89834
0
Prof Janet Hardy
Query!
Address
89834
0
Medical Director Mater Cancer Care Centre
Director Palliative and Supportive Care Services
Mater Misericordiae Ltd
Raymond Terrace
South Brisbane, Qld 4101
Query!
Country
89834
0
Australia
Query!
Phone
89834
0
+61 7 3163 2775
Query!
Fax
89834
0
+61 7 3163 2701
Query!
Email
89834
0
[email protected]
Query!
Contact person for public queries
Name
89835
0
Mrs Georgie Huggett
Query!
Address
89835
0
Clinical Trial Coordinator
Palliative and Supportive Care
Mater Misericordiae Ltd
Raymond Terrace
South Brisbane, Qld 4101
Query!
Country
89835
0
Australia
Query!
Phone
89835
0
+61 7 3163 6057
Query!
Fax
89835
0
+61 7 6163 1588
Query!
Email
89835
0
[email protected]
Query!
Contact person for scientific queries
Name
89836
0
Prof Janet Hardy
Query!
Address
89836
0
Medical Director Mater Cancer Care Centre
Director Palliative and Supportive Care Services
Mater Misericordiae Ltd
Raymond Terrace
South Brisbane, Qld 4101
Query!
Country
89836
0
Australia
Query!
Phone
89836
0
+61 7 3163 2775
Query!
Fax
89836
0
+61 7 3163 2701
Query!
Email
89836
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
This is a double blinded trial, nil data will be provided at this time
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: A double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
2020
https://dx.doi.org/10.1186/s13063-020-04541-6
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF