This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.
Over a 1-2 year period, 40 cancer patients experiencing poorly controlled pain will be enrolled in to a prospective single-arm cohort study, in which they will receive an orally administered cannabis oil formulation as an add-on therapy to current treatment regimens. Subjects entering the acute study phase will be titrated to a tolerated dose at which a sustained pain response is reached, and may subsequently enter a 12 week chronic phase during which safety and durability of pain response will be assessed at their stable dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
RECRUITINGSustained pain response
Two successive pain responses (Reduction in pain as measured by the Brief Pain Inventory - Short form (BPI-SF) with no increase MME or decrease in MME, continuing for 7 days after dose stabilization)
Time frame: 43 days (Acute Phase)
Pain response at any time
Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Toxicity of treatment intervention - incidence and grade of AEs
As measured by NCIC CTE
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Anxiety and depression
As measured by the Hospital Anxiety and Depression Scale (HADS) in which 14 questions are scored on a scale of 0-3. A cumulative score of ≥ 11 will result in a subject being classified as having anxiety and depression using the HADS anxiety and depression, respectively.
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Functional well-being
As measured by the Edmonton Symptom Assessment Scale (ESAS), which is routinely performed in most cancer centres in Ontario, and scores pain as well as other cancer-related symptoms between 0-10, 10 being worst possible.
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Quality of life change
As measured by the Functional Assessment of Cancer Therapy (FACT-G)
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Neuropathic pain
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
As measured by the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a scale which assigns scores between 0-5 to 7 pain-related outcomes, a cut off ≥ 12 classifying subjects as predominantly having neuropathic pain.
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)