Cannabis Oil for Pain Effectiveness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cannabis Oil for Pain Effectiveness

Conditions
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Cancer, Chronic Pain

Intervention / Treatment
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* Drug: MRCP001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with breast, prostate, lung, gastrointestinal or genitourinary cancer who have poorly controlled pain defined by the use of three or more PRN, or as needed, doses of opioids in a 24-hour period for a minimum of three days per week in the week prior to study registration. Age 25-70 years. An ESAS score of 2 or more recorded as their worst pain at the time of study registration. Exclusion Criteria: Current use of cannabis within the last 30 days from date of study consent (urine screen test positive). Brain metastases. ECOG performance > 2. Life expectancy < 6 months. Daily morphine milligram equivalent (MME) dose < 15 or > 120. Current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent or psychosis that could be exacerbated by the administration of cannabis. Chemotherapy induced neuropathy. Poorly controlled hypertension, unstable angina, or myocardial infarction within the previous 6 months. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular (e.g. arrhythmias, ischemic heart disease, tachycardia), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric (e.g. depression, disorientation, euphoric mood and dissociation), dermatological or hematological disease or condition unless determined as not clinically significant. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or are currently pregnant or lactating. Anticipated change in chemotherapy or radiotherapy treatment plan during the 43-day course of the acute study. Known history of substance abuse. Inability to speak or read English. Inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-arm cohort
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRCP001<br>MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID) | Drug: MRCP001<br>* MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.<br>* Other names: Cannabis oil capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained 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) | 43 days (Acute Phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response at any time | Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME | 43 days (Acute Phase) + 12 weeks (Chronic Phase) | 
| Toxicity of treatment intervention - incidence and grade of AEs | As measured by NCIC CTE | 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. | 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. | 43 days (Acute Phase) + 12 weeks (Chronic Phase) | 
| Quality of life change | As measured by the Functional Assessment of Cancer Therapy (FACT-G) | 43 days (Acute Phase) + 12 weeks (Chronic Phase) | 
| Neuropathic pain | 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. | 43 days (Acute Phase) + 12 weeks (Chronic Phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis oil, Cannabis, Pain, Cancer