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Cannabis Oil for Pain Effectiveness (COPE)

Primary Purpose

Cancer, Chronic Pain

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

MRCP001

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cannabis oil, Cannabis, Pain, Cancer

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Juravinski Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRCP001

Arm Description

MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Pain response at any time

Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME

Toxicity of treatment intervention - incidence and grade of AEs

As measured by NCIC CTE

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.

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.

Quality of life change

As measured by the Functional Assessment of Cancer Therapy (FACT-G)

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.

Full Information

NCT ID

NCT03522467

First Posted

April 27, 2018

Last Updated

September 23, 2019

Sponsor

Aurora Cannabis Inc

Collaborators

Ontario Clinical Oncology Group (OCOG), Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03522467

Brief Title

Cannabis Oil for Pain Effectiveness

Acronym

COPE

Official Title

Cannabis Oil for Pain Effectiveness

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 25, 2018 (Actual)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aurora Cannabis Inc

Collaborators

Ontario Clinical Oncology Group (OCOG), Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Chronic Pain

Keywords

Cannabis oil, Cannabis, Pain, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Prospective, single-arm cohort

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRCP001

Arm Type

Experimental

Arm Description

MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)

Intervention Type

Drug

Intervention Name(s)

MRCP001

Other Intervention Name(s)

Cannabis oil capsule

Intervention Description

MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.

Primary Outcome Measure Information:

Title

Sustained pain response

Description

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)

Secondary Outcome Measure Information:

Title

Pain response at any time

Description

Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME

Time Frame