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Cannabis Oil for Pain Effectiveness (COPE)

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ClinicalTrials.gov Identifier: NCT03522467
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : July 30, 2018
Sponsor:
Collaborators:
Ontario Clinical Oncology Group (OCOG)
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
MedReleaf

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Chronic Pain Drug: MRCP001 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-arm cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cannabis Oil for Pain Effectiveness
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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




Primary Outcome Measures :
  1. Sustained pain response [ Time Frame: 43 days (Acute Phase) ]
    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)


Secondary Outcome Measures :
  1. Pain response at any time [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]
    Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME

  2. Toxicity of treatment intervention - incidence and grade of AEs [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]
    As measured by NCIC CTE

  3. Anxiety and depression [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]
    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.

  4. Functional well-being [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]
    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.

  5. Quality of life [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]
    As measured by the Functional Assessment of Cancer Therapy (FACT-G)

  6. Neuropathic pain [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]
    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.



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women with breast, prostate or gastrointestinal 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.
  2. Age 25-70 years.
  3. An ESAS score of 2 or more recorded as their worst pain at the time of study registration.

Exclusion Criteria:

  1. Current use of cannabis within the last 30 days from date of study consent (urine screen test positive).
  2. Brain metastases.
  3. ECOG performance > 2.
  4. Life expectancy < 6 months.
  5. Daily morphine milligram equivalent (MME) dose < 15 or > 120.
  6. Current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent or psychosis that could be exacerbated by the administration of cannabis.
  7. Chemotherapy induced neuropathy.
  8. Poorly controlled hypertension, unstable angina, or myocardial infarction within the previous 6 months.
  9. 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.
  10. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or are currently pregnant or lactating.
  11. Anticipated change in chemotherapy or radiotherapy treatment plan during the 43-day course of the acute study.
  12. Known history of substance abuse.
  13. Inability to speak or read English.
  14. Inability to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522467


Contacts
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Contact: Lisa Rudd-Scott 905-527-2299 ext 43793 ruddl@mcmaster.ca
Contact: Erin McGean 905-527-2299 ext 42656 mcgeane@mcmaster.ca

Locations
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Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Principal Investigator: Marissa Slaven, MD         
Sponsors and Collaborators
MedReleaf
Ontario Clinical Oncology Group (OCOG)
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Marissa Slaven, MD Hamilton Health Sciences Corporation

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Responsible Party: MedReleaf
ClinicalTrials.gov Identifier: NCT03522467     History of Changes
Other Study ID Numbers: OCOG-2017-COPE
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MedReleaf:
Cannabis oil
Cannabis
Pain
Cancer
Additional relevant MeSH terms:
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Chronic Pain
Marijuana Abuse
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders