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Cannabis Oil and Radiation Therapy for the Management of Pain

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ClinicalTrials.gov Identifier: NCT03763851
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
Santé Cannabis
McGill University
Information provided by (Responsible Party):
Tetra Bio-Pharma

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date December 4, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • Cancer pain intensity assessed by Pain Intensity (PI) measurement a numerical rating scale [ Time Frame: Change (a reduction of 30% in pain intensity) in pain intensity after medical cannabis oil administration compared to placebo at 6 weeks compared to baseline ]
    Pain Intensity (PI) measurement a Numerical Rating Scale (zero= no pain and 10= pain as bad as it can be). A reduction of PI ≥ 33% will be considered as a clinically important level of pain relief
  • Cancer pain quality using the Brief Pain Inventory-SF (BPI-SF) [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]
    The BPI-SF consists of nine questions; eight have a single response, and Question 9 is subdivided into seven parts. The Total BPI for Question 9 is the unweighted sum of the seven assessments and represents the effect of pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • Impact of medical cannabis oil combined with radiation treatment on HRQoL as measured by the EQ-5D-5L [ Time Frame: at baseline, 1-week, 3-week, and 6-week follow-up ]
  • Functional status assessed by the Functional Assessment of Cancer Therapy for Prostate patients (FACT-P). [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]
  • Fatigue burden assessed by the Brief Fatigue Inventory (BFI). [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]
  • Cognitive status assessed by the Mini-Cog [ Time Frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabis Oil and Radiation Therapy for the Management of Pain
Official Title  ICMJE Cannabis Oil and Radiation Therapy for the Management of Pain: Assessment of Safety and Efficacy in a Randomized, Double-blind Placebo-controlled Phase II/III Clinical Trial
Brief Summary In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Furthermore, the investigators will assess the effect of medical cannabis oil on health-related quality of life and symptoms that are frequently associated with metastatic cancers including fatigue, anxiety, depression, insomnia and decreased appetite. The safety profile of medical cannabis oil with respect to prolonged use of more than two weeks of administration, concomitant medication use and palliative RT will also be examined.
Detailed Description

This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate tolerability of medical cannabis oil to reduce chronic pain intensity.

Consecutive adult patients between the ages of 18 and 75, male and female, with cancer pain, with an average weekly pain intensity score greater than 4 on the 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial.

Informed consent will be obtained by a Research Assistant.

After baseline documentation with standardized scales, patients will be randomized to one of two parallel groups:

  • Cannabis group: Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule
  • Placebo group: Placebo capsule
  • All patients will receive palliative RT to the symptomatic site. Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis.

Follow-up visits either in person or by phone will be at 1 week, 3 weeks and 6 weeks of treatment.

At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, patients will have the option to receive the active treatment during the 12-week open-label phase if the study physician feels it may potentially provide benefits. Similarly, the dose will be titrated up in the placebo group who wants to receive the active drug in the extension program.

The open-label phase is 12 weeks long. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Prostate Cancer
  • Lung Cancer
  • Breast Cancer
Intervention  ICMJE
  • Radiation: Active PPP005
    Group assigned to active PPP005 in the randomized placebo-controlled trial
  • Radiation: Radiotherapy
    Palliative RadioTherapy to the symptomatic site
Study Arms  ICMJE
  • Experimental: Cannabis group

    Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule

    These capsules contain different cannabis formulations with low-dose and high-dose preparations according to the treatment group:

    • Cannabis group low-dose capsule contains THC 1mg CBD 1mg
    • Cannabis group high-dose capsule contains THC 2.5mg CBD 2.5mg
    Interventions:
    • Radiation: Active PPP005
    • Radiation: Radiotherapy
  • Placebo Comparator: Placebo group
    The placebo capsule will have no cannabis, it will look identical to the active treatment capsule, and it will also be prepared in "low-dose" and "high-dose" presentations.
    Intervention: Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2018)
420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ability to consent to the study-specific written consent form, in English or French;
  2. Adult patients, male and female between the ages of 18 and 75 (inclusively);
  3. Patients with confirmed diagnosis of metastatic carcinoma of the prostate, lung or breast;

    1. No limitation with respect to number of metastases (bone and visceral);
    2. Location of metastases limited to exclude any brain metastases
  4. Patients experiencing an average weekly pain intensity score of 4 or higher on a 11 points NRS and requiring palliative RT;
  5. KPS of equal or higher than 60;
  6. Subject agreed to follow the protocol;
  7. Patients who are referred to receive RT and are non-regular users of cannabis in any form (three times per week or more) and are willing to abstain for 1 week prior and during the study;
  8. Patients receiving opioids and other concomitant pain medications must have a stable dose for the last 15 days;
  9. Normal cognitive status according to MiniCog;
  10. Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
  11. Normal renal function (defined as serum creatinine level <133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) equal or higher than 60)
  12. Negative result on βhuman chorionic gonadotropin pregnancy test (if applicable)
  13. A female volunteer must meet one of the following criteria:

    1. If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.
    2. If of non-childbearing potential - should be surgically sterile or in a menopausal state
  14. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.

Exclusion Criteria:

  1. Patients who are unable to consent or to comply with the instructions of the study;
  2. Patients suffering primarily from pain not related to cancer;
  3. KPS of < 60;
  4. Previous serious adverse event or hypersensitivity to cannabis or cannabinoids;
  5. Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction;
  6. Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5);
  7. Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5;
  8. Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids;
  9. Current suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS);
  10. Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception;
  11. Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level >133 µmol/L.
  12. Cognitive impairment according to MiniCog;
  13. Current use of cannabis in any form more than 3 times per week or use of cannabinoid-based medications within 7 days of study entry and refusal to abstain for the duration of the study;
  14. Positive blood test for cannabinoids at screening or positive urine screening for other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines, unprescribed opioids);
  15. Participation in another clinical trial within 30 days of screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cynthia El Hage, Ph.D (514) 419-4131 ext 1014 cynthia.el.hage@tetrabiopharma.com
Contact: Guy Chamberland, Ph.D guy@tetrabiopharma.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03763851
Other Study ID Numbers  ICMJE PPP005-Ph2/3-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tetra Bio-Pharma
Study Sponsor  ICMJE Tetra Bio-Pharma
Collaborators  ICMJE
  • Santé Cannabis
  • McGill University
Investigators  ICMJE
Principal Investigator: Tamim Niazi, MD Jewish General Hospital, McGill University
Principal Investigator: Jean Zigby, MD Jewish General Hospital, McGill University
PRS Account Tetra Bio-Pharma
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP