CancerPhase 2COPENCT03522467
Cannabis Oil for Pain Effectiveness
A Phase 2 study testing MRCP001 in people with Cancer and Chronic Pain, run by Aurora Cannabis Inc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Cancer, Chronic Pain
- What is being tested?
- MRCP001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jul 2018to Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Marissa Slaven, MD
About this study
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.
Read the 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.
- Conditions
- Cancer, Chronic Pain
- Being tested
- MRCP001
- Keywords
- Cannabis oil, Cannabis, Pain, Cancer
- Medical subject headings
- Neoplasms, Chronic Pain, Marijuana Abuse, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRCP001Drug
Also called Cannabis oil capsule
MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| MRCP001 | Experimental | MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID) Receives: Drug: MRCP001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 43 days (Acute Phase)
Secondary outcomes (6)
Pain response at any time
Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME
Measured: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Toxicity of treatment intervention - incidence and grade of AEs
As measured by NCIC CTE
Measured: 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.
Measured: 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.
Measured: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Quality of life change
As measured by the Functional Assessment of Cancer Therapy (FACT-G)
Measured: 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.
Measured: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start25 Jul 2018
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm cohort
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aurora Cannabis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ontario Clinical Oncology Group (OCOG), Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Marissa Slaven, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522467
- Sponsor's protocol ID
- OCOG-2017-COPE
- Acronym
- COPE
- Status last verified
- Sep 2019
- First submitted
- 27 Apr 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Oil for Pain Effectiveness
- ClinicalTrials.gov ID
- NCT03522467
- Acronym / sponsor ID
- COPE / OCOG-2017-COPE
- Conditions
- Cancer, Chronic Pain
- Keywords
- Cannabis oil, Cannabis, Pain, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aurora Cannabis IncIndustry (pharma, biotech, devices)
- Collaborators
- Ontario Clinical Oncology Group (OCOG), Hamilton Health Sciences Corporation
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm cohort
| Arm | Type | Receives |
|---|---|---|
| MRCP001 | Experimental | Drug: MRCP001MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRCP001Also: Cannabis oil capsuleMRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain. | Drug | MRCP001 |
Primary outcome
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)
6 secondary outcomes
Pain response at any time
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Toxicity of treatment intervention - incidence and grade of AEs
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Anxiety and depression
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Functional well-being
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Quality of life change
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Neuropathic pain
Time frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa Slaven, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRCP001 in people with Cancer and Chronic Pain, run by Aurora Cannabis Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Rudd-Scott (905-527-2299 ext. 43793, ruddl@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained pain response (time frame: 43 days (Acute Phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.