Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000974707
Ethics application status
Approved
Date submitted
4/07/2022
Date registered
11/07/2022
Date last updated
7/04/2024
Date data sharing statement initially provided
11/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the ability to detect tetrahydrocannabinol (THC) from cannabidiol (CBD) dominant medicinal cannabis products in patient samples of saliva, blood, and urine
Scientific title
An open label pilot study investigating the in vivo detection of tetrahydrocannabinol (THC) in cannabidiol (CBD) dominant cannabinoid medications in cancer patients
Secondary ID [1] 307469 0
NIL
Universal Trial Number (UTN)
Trial acronym
MedCan - DRIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 326878 0
Condition category
Condition code
Cancer 324089 324089 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be offered a 50mL bottle of LGP Classic CBD 50, LGP Classic 1:100 or LGP Classic 1:20 according to doctor/patient preference and product availability.

LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL) oral solution (dose range 0.05mg/12.5mg - 0.4mg/100mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will increase by 0.5mls every 3 days. The day 14 dose is then continued for day 15 - 27. If the participant experienced adverse effects the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required.
Participants are required to bring the study drug to each study visit for monitoring and compliance of mls (volume) remaining in the bottle.

LGP Classic 1:100 (THC/CBD 1.5mg/100mg per mL) oral solution (dose range 0.375mg/25mg - 3mg/200mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will increase by 0.5mls every 3 days. The day 14 dose is then continued for day 15 - 27. If the participant experienced adverse effects the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required.
Participants are required to bring the study drug to each study visit for monitoring and compliance of mls (volume) remaining in the bottle.

LGP Classic CBD 1:20 (THC/CBD 1mg/20mg per mL) oral solution (dose range 0.25mg/5mg - 2mg/40mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will increase by 0.5mls every 3 days. The day 14 dose is then continued for day 15 - 27. If the participant experienced adverse effects the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required.
Participants are required to bring the study drug to each study visit for monitoring and compliance of mls (volume) remaining in the bottle.
Intervention code [1] 323934 0
Treatment: Drugs
Comparator / control treatment
LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL) oral solution (dose range 0.05mg/12.5mg - 0.4mg/100mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will increase by 0.5mls every 3 days. The day 14 dose is then continued for day 15 - 27. If the participant experienced adverse effects the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required.
Participants are required to bring the study drug to each study visit for monitoring and compliance of mls (volume) remaining in the bottle.
Control group
Dose comparison

Outcomes
Primary outcome [1] 331885 0
Detection of THC (yes/no) in urine samples of people taking CBD dominant products. Urine will be assessed using lateral flow assay detection devices.
Timepoint [1] 331885 0
Baseline, days 7, 14 & 28 (primary endpoint) after study drug started
Primary outcome [2] 331934 0
Detection of THC (yes/no) saliva samples of people taking CBD dominant products. Saliva will be assessed using lateral flow assay detection devices.
Timepoint [2] 331934 0
Baseline, days 7, 14 & 28 (primary endpoint) after study drug started
Primary outcome [3] 331935 0
Detection of THC (yes/no) blood samples of people taking CBD dominant products. Blood samples will be analysed using a validated LCMSMS (liquid chromatography-tandem mass spectrometry) method for THC and CBD,
Timepoint [3] 331935 0
Baseline, days 7, 14 & 28 (primary endpoint) after study drug startedoint)
Secondary outcome [1] 411502 0
Change from baseline of Edmonton Symptom Assessment Scale Total Symptom Distress Score (ESAS TSDS).
Timepoint [1] 411502 0
Baseline and days 7, 14 & 28 after study drug started
Secondary outcome [2] 411503 0
Patient-determined effective doses of CBD dominant products, defined as the dose that achieves symptom relief with acceptable side-effects. Patients will use a specifically designed dosage schedule
Timepoint [2] 411503 0
Days 7, 14 & 28 after study drug started
Secondary outcome [3] 411504 0
Composite ESAS symptom scores (Physical: pain, fatigue, nausea, drowsiness, appetite, dyspnoea; Emotional: depression, anxiety; Well-being) on days of medical review
Timepoint [3] 411504 0
Baseline and days 7, 14 & 28 after study drug started
Secondary outcome [4] 411505 0
Clinical Global Impression scale (CGI) score assessing change in overall condition will be assessed on medical review days.
Timepoint [4] 411505 0
Days 7, 14 & 28 after study drug started
Secondary outcome [5] 411506 0
Known/possible adverse events will be assessed via phone calls and medical review days.
All adverse events will be assessed by participant self-reporting, or physical examination by the research nurse/clinician
Known adverse events may include: Disorientation, dizziness, euphoria, confusion, drowsiness, dry mouth, somnolence, balance, hallucinations, nausea, paranoia, weakness, fatigue, anxiety, vomitig, diarrhoea, abdominal pain, depression, psychosis.
All adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03
Timepoint [5] 411506 0
Phone calls: days 2, 10, and 21 after study drug started
Medical review days: days 7, 14, and 28 after study drug started

Eligibility
Key inclusion criteria
Patients with histologically proven cancer known to the Cancer Care Service who:
- Have had an ESAS TSDS greater than or equal to 10 for cancer or cancer-treatment-related symptoms, and at least one individual ESAS score greater than or equal to 3
- Performance Status AKPS (Australia-modified Karnofsky Scale score) of greater than or equal to 30
- Aged 18 years, English-speaking (or have an interpreter available)
- Have a negative THC urine test at baseline
- 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
- Are able to tolerate oral medications
- Are willing to receive standard palliative care as necessary and delivered by their primary treating team
- Physician assessed ability to comply with all trial requirements, agree to attend scheduled clinic appointments and adhere to dose titration schedules as directed
- Agree to use no other cannabis-based products for the duration of the trial
- Understand that 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
- Able to provide fully informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with:
- A history of hypersensitivity to any cannabinoid
- Unstable untreated cardiovascular disease (hypertension, ischaemic heart disease, congestive cardiac failure)
- Severe hepatic impairment (total bilirubin greater than or equal to 1.5 times the upper limit of the institution’s normal range. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than or equal to 3.0 time the upper limit of the institution’s normal range; subjects with liver metastasis AST and ALT of greater than or equal to 5.0 times the upper limit of normal
- Severe renal impairment (eGFR greater than or equal to 20mL/min/1.73m2)
- A history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, schizophrenia)
- Known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening Test) examination scoring greater than or equal to 27 for any substance
- History suggesting that drug diversion may be a risk for them or their family/carers
- Females who are pregnant or lactating
- Concurrent or participation in a trial of a new clinical entity within the last 28 days
- Treatment with a new specific anticancer agent (chemotherapy, hormone therapy, targeted or immunotherapy or radiation within the last 7 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a pilot study, data will be analysed using descriptive statistics only. The aim is to recruit 30 participants over a twelve-month period in a pilot study pending progression to a larger, fully powered study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/08/2022
Actual
27/03/2023
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
30
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22685 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 22686 0
Mater Private Hospital - South Brisbane
Recruitment hospital [3] 22687 0
Mater Private Hospital Springfield - Springfield Central
Recruitment hospital [4] 22688 0
Mater Private Hospital Redland - Cleveland
Recruitment postcode(s) [1] 37964 0
4101 - South Brisbane
Recruitment postcode(s) [2] 37966 0
4163 - Cleveland
Recruitment postcode(s) [3] 37965 0
4300 - Springfield Central

Funding & Sponsors
Funding source category [1] 311746 0
Government body
Name [1] 311746 0
National Health and Medical Research Council (NHMRC)/Medical Research Future Fund (MRFF)
Country [1] 311746 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Limited
Address
Mater Misericordiae Ltd
Raymond Terrace
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 313206 0
University
Name [1] 313206 0
The University of Queensland
Address [1] 313206 0
St Lucia Qld 4072
Country [1] 313206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311190 0
Mater Misericordiae Ltd Human Research Ethics Committee (EC00332)
Ethics committee address [1] 311190 0
Level 2, Aubigny Place,
Raymond Tce, South Brisbane, Qld, 4101.
Ethics committee country [1] 311190 0
Australia
Date submitted for ethics approval [1] 311190 0
04/07/2022
Approval date [1] 311190 0
01/08/2022
Ethics approval number [1] 311190 0

Summary
Brief summary
Medicinal cannabis predominantly containing cannabidiol (CBD) is often prescribed for the relief of cancer symptoms. However, it is illegal to drive in Queensland while taking tetrahydrocannabinol (THC) irrespective of whether it is for recreational or medicinal use. Unfortunately, very few CBD dominant products are completely free of THC, with most products containing traces of THC. Whether a CBD-dominant preparation with trace THC taken as an oil preparation would return a positive result on a roadside screening test is an important gap in the literature. Therefore, the aim of this study is to assess whether THC is detectable in saliva, blood, and urine after administration of CBD-dominant medicinal cannabinoid preparations in cancer patients.

Who is it for?
You may be eligible for this study if you are aged 18 years or over, have been diagnosed with cancer, are known to the Cancer Care Service, and are experiencing cancer-related symptoms.

Study details
Participants will be allocated to one of three treatment groups based upon doctor/patient preference and product availability, involving either LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL), LGP Classic 1:100 (THC/CBD 1.5mg/100mg per mL), or LGP Classic CBD 1:20 (THC/CBD 1mg/20mg per mL) administered as an oral solution. Treatment will be administered for a total of 27 days, starting at a dose of 0.25ml daily and increasing every 3 days for the first 14 days, reaching a max dose of 1ml twice a day. The day 14 dose is then continued for days 15 - 27. If the participant experiences adverse effects, the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants will be asked to return for study visits on days 7, 14, and 28 after commencing the treatment to collect saliva, urine, and blood samples for the detection of THC. During these visits, questionnaires regarding cancer symptoms will also be completed, as well as an assessment of any adverse effects experienced as a result of treatment.

It is hoped that this study may show that CBD-dominant preparations do not produce a detectable level of THC in clinical samples, while showing an improvement in cancer symptoms with minimal side effects. This may help to inform advice given to patients taking medicinal cannabinoid preparations in future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120266 0
Prof Janet Hardy
Address 120266 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place,
Raymond Tce, South Brisbane, Qld, 4101
Country 120266 0
Australia
Phone 120266 0
+61731632775
Fax 120266 0
Email 120266 0
janet.hardy@mater.org.au
Contact person for public queries
Name 120267 0
Mrs Georgie Huggett
Address 120267 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place,
Raymond Tce, South Brisbane, Qld, 4101
Country 120267 0
Australia
Phone 120267 0
+61731636057
Fax 120267 0
Email 120267 0
georgie.huggett@mater.org.au
Contact person for scientific queries
Name 120268 0
Prof Janet Hardy
Address 120268 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place,
Raymond Tce, South Brisbane, Qld, 4101
Country 120268 0
Australia
Phone 120268 0
+61731632775
Fax 120268 0
Email 120268 0
janet.hardy@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be uploaded/shared on accessible databases.


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
No additional documents have been identified.