Preliminary assessment of the anti-inflammatory effects of THC and CBD in cancer patients.
- Conditions
- CancerCancer - Any cancer
- Registration Number
- ACTRN12623000878673
- Lead Sponsor
- Mater Misericordiae Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum inflammatory markers: C- Reactive protein (CRP)[ .Days 0 (baseline), 14 and 28 after commencing dosing of THC/CBD 1:20];Change in serum inflammatory markers: Interleukin-1 (IL-1) [ Days 0 (baseline), 14 and 28 after commencing dosing of THC/CBD 1:20];Change in serum inflammatory markers: Interleukin-6 (IL-6) [ Days 0 (baseline), 14 and 28 after commencing dosing of THC/CBD 1:20.]
- Secondary Outcome Measures
Name Time Method .Nil[ Nil.]