Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
Trial registered on ANZCTR


Registration number
ACTRN12623000878673p
Ethics application status
Submitted, not yet approved
Date submitted
12/07/2023
Date registered
16/08/2023
Date last updated
16/08/2023
Date data sharing statement initially provided
16/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Preliminary assessment of the anti-inflammatory effects of THC and CBD in cancer patients.
Scientific title
Exploring potential anti-inflammatory effects of THC/CBD 1:20 medicinal cannabis product in patients with advanced cancer
Secondary ID [1] 309456 0
NIL
Universal Trial Number (UTN)
Trial acronym
Cann-Inflam
Linked study record
Related to study ACTRN12622000083796. Patients who are randomised to MedCan 3 - THC/CBD will be offered to participate in this study.

Health condition
Health condition(s) or problem(s) studied:
Cancer 329707 0
Condition category
Condition code
Cancer 326607 326607 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be those who have consented and are eligible to participate in MedCan 3 (ACTRN12622000083796).

Measurement of a panel of inflammatory markers and different immune cell populations in serum and blood respectively from participants who are currently participating in the randomized, blinded, placebo-controlled trial of tetrahydrocannabinol/cannabidiol (THC/CBD) 1:20 (MedCan 3). Participants will be required to provide a blood sample at days 0 (baseline), 14 and 28 after commencing dosing of THC/CBD 1:20 in MedCan 3. Participants will be reviewed in person on those days.
Intervention code [1] 325877 0
Treatment: Drugs
Comparator / control treatment
Placebo oral solution 50mL bottle; identical ingredients except the active ingredients of THC and CBD triglycerides oil.
All participants recruited in MedCan 3 1:20 will require bloods at days 0 (baseline), 14 & 28.
Control group
Placebo

Outcomes
Primary outcome [1] 334462 0
Change in serum inflammatory markers: C- Reactive protein (CRP)
Timepoint [1] 334462 0
.Days 0 (baseline), 14 and 28 after commencing dosing of THC/CBD 1:20
Primary outcome [2] 335701 0
Change in serum inflammatory markers: Interleukin-1 (IL-1)
Timepoint [2] 335701 0
Days 0 (baseline), 14 and 28 after commencing dosing of THC/CBD 1:20
Primary outcome [3] 335702 0
Change in serum inflammatory markers: Interleukin-6 (IL-6)
Timepoint [3] 335702 0
Days 0 (baseline), 14 and 28 after commencing dosing of THC/CBD 1:20.
Secondary outcome [1] 420785 0
.Nil
Timepoint [1] 420785 0
Nil.

Eligibility
Key inclusion criteria
Patients who consent and are eligible for MedCan 3 - THC/CBD 1:20 (ACTRN12622000083796).

Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:
- Have an Edmonton Symptom Assessment System Total Symptoms Distress Score (ESAS TSDS) greater than or equal to 10 for cancer-related symptoms, and at least one individual ESAS score greater than or equal to 3 (for sleep component need to have a sleep numeric rating scale (NRS) score greater than or equal to 3)
- Performance Status AKPS (Australia-modified Karnofsky Scale score) of greater than or equal to 30
- Are aged 18 years, English-speaking (or have an 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 at eligibility for previous cannabinoid use
- Are able to tolerate oral medications
- Are willing to receive standard palliative care as delivered by their primary treating team
- Can comply with all trial requirements: agree to attend scheduled clinic appointments, 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
- Are 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
Nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/08/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24515 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 40104 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 313644 0
Other Collaborative groups
Name [1] 313644 0
Mater Research
Country [1] 313644 0
Australia
Funding source category [2] 314541 0
Hospital
Name [2] 314541 0
Translational Research Institue
Country [2] 314541 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Limited
Address
Raymond Terrace
South Brisbane Qld 4101
Country
Australia
Secondary sponsor category [1] 315436 0
Other
Name [1] 315436 0
Translational Research Institue
Address [1] 315436 0
37 Kent Street
Woolloongabba Qld 4102
Country [1] 315436 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312812 0
Mater Misericordiae Ltd Human Research Ethics Committee (EC00332)
Ethics committee address [1] 312812 0
Level 2 Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Ethics committee country [1] 312812 0
Australia
Date submitted for ethics approval [1] 312812 0
21/07/2023
Approval date [1] 312812 0
Ethics approval number [1] 312812 0

Summary
Brief summary
The role of inflammation has been described in the aetiology, early detection and prognosis of cancer as reflected by a range of inflammatory makers. Inflammation is also thought to play a significant role in the expression of cancer-related symptoms. Examples include elevation of CRP and TNF in head and neck cancer pain, CRP and Interleukin (IL)-1 receptor antagonist in fatigue during radiation therapy, and IL-6 and MIP1 alpha reflecting symptom burden in myeloma.
This study proposes to investigate the inflammatory markers and immune cells as a pilot sub-study within our main MRFF funded randomised controlled trial of 1:20 THC:CBD medicinal cannabis product versus placebo in symptomatic patients with advanced cancer.

Who is it for?
You will be eligible for this study if you consent and pass eligibility to MedCan 3 - THC/CBD 1:20

Study details
The study is a single site study. Serum is collected at baseline and day 14 in the current study. In participants consenting to the sub-study, blood for inflammatory markers will be taken at baseline, days 14 and 28. Serum will be frozen and stored until samples from 30 participants have been collected. All samples will be analysed for inflammatory markers.

If there is a positive result showing an improvement in inflammation markers it may lead to a larger, adequately powered study of the anti-inflammatory effects of THC/CBD 1:20 in cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126006 0
Dr Taylan Gurgenci
Address 126006 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Country 126006 0
Australia
Phone 126006 0
+61731636379
Fax 126006 0
Email 126006 0
t.gurgenci@uq.edu.au
Contact person for public queries
Name 126007 0
Mrs Georgie Huggett
Address 126007 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Country 126007 0
Australia
Phone 126007 0
+61731636057
Fax 126007 0
Email 126007 0
georgie.huggett@mater.org.au
Contact person for scientific queries
Name 126008 0
Dr Taylan Gurgenci
Address 126008 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Country 126008 0
Australia
Phone 126008 0
+61731636379
Fax 126008 0
Email 126008 0
t.gurgenci@uq.edu.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.