NCT03522467

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 cancer

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

April 27, 2018

Last Update Submit

September 23, 2019

Conditions

CancerChronic Pain

Keywords

Cannabis oilCannabisPainCancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Pain response at any time

    43 days (Acute Phase) + 12 weeks (Chronic Phase)

  • Toxicity of treatment intervention - incidence and grade of AEs

    43 days (Acute Phase) + 12 weeks (Chronic Phase)

  • Anxiety and depression

    43 days (Acute Phase) + 12 weeks (Chronic Phase)

  • Functional well-being

    43 days (Acute Phase) + 12 weeks (Chronic Phase)

  • Quality of life change

    43 days (Acute Phase) + 12 weeks (Chronic Phase)

  • +1 more secondary outcomes

Study Arms (1)

MRCP001

EXPERIMENTAL

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

Drug: MRCP001

Interventions

MRCP001DRUG

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

Also known as: Cannabis oil capsule
MRCP001

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

MeSH Terms

Conditions

NeoplasmsChronic PainMarijuana AbusePain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Marissa Slaven, MD

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Rudd-Scott

CONTACT

905-527-2299ruddl@mcmaster.ca

Erin McGean

CONTACT

905-527-2299mcgeane@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, single-arm cohort
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 11, 2018

Study Start

July 25, 2018

Primary Completion

June 1, 2020

Study Completion

September 1, 2020

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)