None listed
Conditions
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.
Interventions
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 commenci
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.
Sponsors
Mater Misericordiae Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
Nil
Outcome results
None listed