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Medical marijuana
Does it have a role in the
treatment of cancer
patients?
Paul Daeninck, MD MSc FRCPC
Departments of Internal & Family Medicine
University of Manitoba and CancerCare Manitoba
Objectives
At the end of this event, participants will
learn about:
1. Basic facts about medical cannabis in
Canada
2. The role of medical cannabis for cancer
patients
3. How to access medical cannabis under the
current Health Canada process
Ma-fen is used for waste
diseases and injuries; it clears
blood and…it undoes
rheumatism. If taken in excess
it produces hallucinations and a
staggering gait. If taken over
a long term it causes one to
communicate with spirits and
lightens one’s body
Ancient Chinese Herbal, c. 2700 BC
Russo et al, 2008
Cannabis in History
Food and oil (seeds)
Fibre
(stems)
Drug /
Medicine
(flowers)
A few definitions…
Cannabis: plant material, cannabis sativa,
cannabis indica, hemp, marijuana
Cannabinoid: group of active compounds
found in cannabis (e.g., THC, CBD, CBG, etc)
Endocannabinoid system: includes
receptors (CB1, CB2), ligands (2-AG),
enzymes (FAAH)
Time
Nov 22/2010
How does cannabis work?
Cannabis sativa
Marijuana (dried leaves / flowering heads)
Isolated pure compounds
Non-cannabinoids Cannabinoids
Psychoactive
Δ9-THC
Δ8-THC
cannabinol (weak)
Active, not
psychoactive
cannabidiol
Inactive
> 80
compounds
> 400 chemical
compounds
> 70 types of
cannabinoids
Most potent
psychoactive
ingredient
Cannabis: What’s in it?
Kalant H. Pain Res Manage 2001;6:80-91
active in several conditions
1) Neurotransmitter (NT) released
from vesicles within the
presynaptic neuron activates the
postsynaptic neuron
2) Activation of postsynaptic neuron
leads to synthesis and release of
endocannabinoid
3) The endogenous CB1 ligand
diffuses back to and binds to the
presynaptic CB1 receptor
4) The CB1 receptor activates a
G-protein, which lead to
presynaptic events that result in
inhibition of NT release
5) Exogenous drugs directly activate
CB1 receptors to stimulate the
endogenous cannabinoid system,
enhancing its function
5
1
2
4
3
Cappendijk S Modulators of Drug Dependence Phenomena 2010
Mackie K Ann Rev Pharmacol Toxicol 2006,46:101-122
Endocannabinoids
Immune function
Inflammation
Appetite
Metabolism and energy
homeostasis
Cardiovascular function
Digestion
Bone development and
bone density
Pain
Reproduction
Psychiatric disease
Psychomotor behavior
Memory
Wake/sleep cycles
Regulation of stress and
emotional state
Learning
Evidence supports the role of endocannabinoids in:
Who is using
medical
cannabis?
Who uses cannabis as
medicine?
2% use cannabis for medical purposes (2000)
>37,000 people registered with MMAR (Mar 2013)
approx 6% cancer Dx
>50,000 people registered with MMPR (Mar 2016)
>98,000 registrants with ACMPR (Sept 2016)
No epidemiology studies done in cancer or
palliative care patients
Ogborne, CMAJ 2000
Health Canada information
Market data from Health Canada
Hazekamp et al, J Psycho Drugs, 2013
Hazekamp et al, J Psycho Drugs, 2013
Time Nov 22/2010
Why are
people
asking for
cannabis?
What is the
evidence?
On-label indications:
Nausea and vomiting from chemotherapy
Chronic pain (neuropathic pain in MS and cancer)
Anorexia associated with HIV / AIDS
Off-label indications/emerging evidence for:
Neuropathic / mixed pain
Chronic daily headache
Anorexia / cachexia
Spasticity
Epilepsy
Cannabinoid indications
PTSD
Anxiety
Insomnia
Spasticity (MS)
Bladder spasms (MS)
Fibromyalgia
Symptom prevalence in
cancer patients
Pain
Depression
Anxiety
Confusion (delirium)
Fatigue
Breathlessness (dyspnea)
Nausea
Constipation
Anorexia
35 - 96%
3 - 77%
13 - 79%
6 - 93%
32 - 90%
10 - 70%
6 - 68%
23 - 65%
30 - 92%
Solano et al, JPSM 2006; 31: 58-69
Symptoms responsive to
cannabinoids
Pain
Depression
Anxiety
Confusion (delirium)
Fatigue
Breathlessness (dyspnea)
Nausea
Constipation
Anorexia
What is the evidence?
Pain
Pre-clinical
Clinical
Evidence
++
+++
Pre-clinical data: Pain
Robust in vitro evidence cancer pain
responds to cannabinoid treatment
Use in bone pain/neuropathic pain has
strongest evidence
Direct use of agonists/antagonists and
prevention of enzyme degradation
Peripheral application effective, few A/E
Clinical data: Pain
Trial evidence supports oral use in cancer
pain, in addition to usual therapy
Small studies using smoking/vaporization
None using edibles or oils
Reduction in use of pain meds noted
Few A/E
Conclusions of reviews
Studies small, short in duration, modest
effect size
“cannabinoids are safe, demonstrate a
modest analgesic effect and provide a
reasonable treatment option for chronic
non-cancer pain”
CPS neuropathic pain
guideline revision
Add additional agents
sequentially if partial but
inadequate pain relief
Tramadol or Controlled-release opioid analgesic
Fourth-line agents†
Cannabinoids
TCA Gabapentin or pregabalin SNRI ‡
†methadone, lamotrigine, topiramate, valproic
acid, lidocaine.
‡Do not add SNRIs to TCAs
Pain Res Manage 2014;19(6):328-335
What is the evidence?
Nausea
Pre-clinical
Clinical
Evidence
++
+++
Martin BR & Willey JL. J Support Onc 2004;2: 305-16
Cannabinoids in nausea
CBs may be superior to conventional therapies in low-
medium emetogenic setting
Patient preference for CBs ranged from 38-90% (P 4-20%)
CBs produced significantly more A/E effects (good & bad),
more pt withdrawals
“In selected patients, cannabinoids may be useful as
mood enhancing adjuvants for the control of
chemotherapy related sickness”
BMJ 2001, 323:1-8
Inhaled marijuana
Three studies, associated with chemo
administration
Some new users, many previous
cannabis users
All studies showed benefit, but high
incidence of side effects
25-35% pts prefer marijuana
Vinciguerra et al, N Y State J Med 1988 88:525
Chang et al, Ann Int Med 1979 91:819
Levitt et al, JCO 1984 abstract C-354
What is the evidence?
Appetite/wt loss
Pre-clinical
Clinical
Evidence
++
+
Marijuana flips
appetite switch in
brain
Sudden attacks of 'the
munchies’ triggered by
changes in hormone pro-
opiomelanocortin (POMC)
release by neurons
doi:10.1038/nature.2015.16957
doi: 10.1038/nature14260
Jatoi A et al. J Clin Oncol 2002;20:567-573
Nelson K et al. J Pall Care 1994;10:14-18
Timpone JG et al. AIDS Res Hum Retroviruses 1997;13:305-15
Struwe M et al. Ann Pharmacother 1993;27:827-31
Beal JE et al. J Pain Symptom Manage 1995;10:89-97
Beal JE et al. J Pain Symptom Manage 1997;14:7-14
Appetite and weight loss
Dronabinol: taste alterations
Pilot trial to improve taste, smell changes in advanced
cancer patients
THC 2.5 mg BID or TID vs placebo x 18 days, n=21
Questionnaires / interviews revealed significant
improvement in taste / smell, increased appetite and
protein intake
QoL measures found improved relaxation, quality of
sleep
Adverse effects same in both groups
TD Brisbois Clarkson et al, Ann Oncol 2011; 22: 2086-93
What is the evidence?
Neuroprotection
Pre-clinical
Clinical
Evidence
+/-
+
What is the evidence?
Insomnia
Pre-clinical
Clinical
Anxiety
Pre-clinical
Clinical
Evidence
-
++*
++
-
*secondary finding
Cannabinoids and anxiety
Oral cannabinoids used for nausea
produces sedation and reduces
anxiety
Very low dose cannabis can
produce sedation, diminish anxiety
without getting high
Cannabidiol can exert anti-anxiety
effects, although only demonstrated
in acute, experimentally-induced
anxiety
Tramer et al, BMJ 2001; 323:1-8
Graham and Li, Cannabis and Health, 1976
Bergamaschi et al, Neuropsychopharmcol 2011; 36: 1219-26
20 Medical Studies That Prove
Cannabis Can Cure Cancer
http://www.collective-evolution.com/2013/08/23/20-medical-studies-that-prove-
cannabis-can-cure-cancer/#sthash.H5ypYS6a.dpuf
Cannabis Cures Cancer
https://dl.dropboxusercontent.com/u/27713298/Web/cure/How_It_Works.html
Run From The Cure: How Cannabis
Cures Cancer And Why No One Knows
Cannabis sativa hemp, the miracle plant, contains the cure for cancer and
other ailments By Rick Simpson - Friday, March 7 2008
http://www.cannabisculture.com/articles/5169.html
What is the evidence?
Cancer
Pre-clinical
Clinical
Clinical trials
Evidence
+++
nil
- In Progress
Cannabis is not a cure for
cancer
What should
one know
about
obtaining
medical
cannabis in
Canada?
Prescription cannabinoids
Dronabinol (Δ-9 tetrahydrocannabinol – THC) (2.5 - 10mg)
Oral capsule
Approved for chemotherapy-induced nausea and vomiting and
anorexia associated with HIV/AIDS
Nabilone (0.25 - 1.0mg)
Oral capsule
Approved for chemotherapy-induced nausea and vomiting
Nabiximols (2.5mg THC + 2.7mg CBD)
Oromucosal spray
Approved in Canada for multiple sclerosis-associated
neuropathic pain, spasticity and advanced cancer pain
Female flowers (“buds”) are rich in cannabinoids (e.g. THC)
Smoked
Herbal cannabis-joints, pipes
Vaporized
Herbal cannabis heated to release cannabinoids but
prevent burning
Oral / buccal
Tinctures (alcoholic extracts)
Oils and edible products (cookies, brownies, etc.)
Sublingual spray (nabiximols by prescription)
Topical
Balms, lotions and salves
Medicinal cannabis products
Health Canada website
36 Licensed Producers to date
Patient confusion over who to choose
What distinguishes one LP over another?
Is the product safe?
What does “Jack the Ripper” and “Green
Kush” mean?
Supply availability?
http://www.hc-sc.gc.ca/dhp-
mps/marihuana/info/list-eng.php
Cannabis strains
Thousands of cannabis strains exist
34 licensed producers listed >300 strains
Most strains were developed for recreational use
and still use common names
high THC (15-20%), very low CBD (<1%)
mod CBD (9-15%), low THC (1-4%)
THC=CBD
Oils (THC>CBD, THC=CBD, THC<CBD)
Varying amounts of minor cannabinoids (CBC, THCV,
etc.), terpenoids, flavonoids
Page, 2014
Medical cannabis: Is it different
than street marijuana?
Grown under strict Good Production Practices (GPP)
guidelines enforced by Health Canada
Most producers have industrial size “grow-ops”
Products tested for microbials, mycotoxins, metals and
pesticides
Delivered to the patient in a safe and secure manner
Concentrations of cannabinoids captured on label
(usually THC and CBD)
Recall ability given lot designation
Precautions and
contraindications
Contraindications:
Psychosis/schizophrenia
Unstable heart disease
Pregnancy
Age under 21-25 (cognitive development)
Ask about:
History of legal issues/criminal charges
Screening for other drug use
Prior recreational cannabis use
Adverse effects
Drowsiness
Dry mouth
Delirium/psychosis
Cognition
Hyperemesis
Dependence
Interactions
Respiratory effects
Spermatogenesis
Neurodevelopment
Patient Symptoms where
conventional
treatments have
failed
Compassionate end-
of-life care or
specified medical
conditions
Current ACMPR process
PatientCompassionate end-
of-life care or
specified medical
conditions A physician
completes a
medical
document on
behalf of
patient for
access to
medicinal
marijuana
Current ACMPR process
Patient
Current ACMPR process
The patient sends an
application form to the
Licensed Producer of
their choice.
Patient
Current ACMPR process
The Licensed Producer
validates the client’s medical
document / application form and
adds them as a client. Once the
client orders product, it is then
shipped via secured courier to
their door.
Licensed
Producer
Mailing Address
Product choice
Health Care
Practitioner
Information
Patient
Information
Written
Order
Physician
Attestation,
Signature
Summary
Cannabis & cannabinoids active in
supportive care for cancer patients
Clinical benefits in: pain, nausea, appetite
More research is needed

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Medical Marijuana - Does it Have a Role in the Treatment of Cancer Patients?

  • 1. Medical marijuana Does it have a role in the treatment of cancer patients? Paul Daeninck, MD MSc FRCPC Departments of Internal & Family Medicine University of Manitoba and CancerCare Manitoba
  • 2. Objectives At the end of this event, participants will learn about: 1. Basic facts about medical cannabis in Canada 2. The role of medical cannabis for cancer patients 3. How to access medical cannabis under the current Health Canada process
  • 3. Ma-fen is used for waste diseases and injuries; it clears blood and…it undoes rheumatism. If taken in excess it produces hallucinations and a staggering gait. If taken over a long term it causes one to communicate with spirits and lightens one’s body Ancient Chinese Herbal, c. 2700 BC
  • 4. Russo et al, 2008 Cannabis in History Food and oil (seeds) Fibre (stems) Drug / Medicine (flowers)
  • 5. A few definitions… Cannabis: plant material, cannabis sativa, cannabis indica, hemp, marijuana Cannabinoid: group of active compounds found in cannabis (e.g., THC, CBD, CBG, etc) Endocannabinoid system: includes receptors (CB1, CB2), ligands (2-AG), enzymes (FAAH)
  • 6. Time Nov 22/2010 How does cannabis work?
  • 7. Cannabis sativa Marijuana (dried leaves / flowering heads) Isolated pure compounds Non-cannabinoids Cannabinoids Psychoactive Δ9-THC Δ8-THC cannabinol (weak) Active, not psychoactive cannabidiol Inactive > 80 compounds > 400 chemical compounds > 70 types of cannabinoids Most potent psychoactive ingredient Cannabis: What’s in it? Kalant H. Pain Res Manage 2001;6:80-91 active in several conditions
  • 8. 1) Neurotransmitter (NT) released from vesicles within the presynaptic neuron activates the postsynaptic neuron 2) Activation of postsynaptic neuron leads to synthesis and release of endocannabinoid 3) The endogenous CB1 ligand diffuses back to and binds to the presynaptic CB1 receptor 4) The CB1 receptor activates a G-protein, which lead to presynaptic events that result in inhibition of NT release 5) Exogenous drugs directly activate CB1 receptors to stimulate the endogenous cannabinoid system, enhancing its function 5 1 2 4 3 Cappendijk S Modulators of Drug Dependence Phenomena 2010 Mackie K Ann Rev Pharmacol Toxicol 2006,46:101-122
  • 9. Endocannabinoids Immune function Inflammation Appetite Metabolism and energy homeostasis Cardiovascular function Digestion Bone development and bone density Pain Reproduction Psychiatric disease Psychomotor behavior Memory Wake/sleep cycles Regulation of stress and emotional state Learning Evidence supports the role of endocannabinoids in:
  • 11. Who uses cannabis as medicine? 2% use cannabis for medical purposes (2000) >37,000 people registered with MMAR (Mar 2013) approx 6% cancer Dx >50,000 people registered with MMPR (Mar 2016) >98,000 registrants with ACMPR (Sept 2016) No epidemiology studies done in cancer or palliative care patients Ogborne, CMAJ 2000 Health Canada information
  • 12. Market data from Health Canada
  • 13.
  • 14. Hazekamp et al, J Psycho Drugs, 2013
  • 15. Hazekamp et al, J Psycho Drugs, 2013
  • 16. Time Nov 22/2010 Why are people asking for cannabis? What is the evidence?
  • 17. On-label indications: Nausea and vomiting from chemotherapy Chronic pain (neuropathic pain in MS and cancer) Anorexia associated with HIV / AIDS Off-label indications/emerging evidence for: Neuropathic / mixed pain Chronic daily headache Anorexia / cachexia Spasticity Epilepsy Cannabinoid indications PTSD Anxiety Insomnia Spasticity (MS) Bladder spasms (MS) Fibromyalgia
  • 18. Symptom prevalence in cancer patients Pain Depression Anxiety Confusion (delirium) Fatigue Breathlessness (dyspnea) Nausea Constipation Anorexia 35 - 96% 3 - 77% 13 - 79% 6 - 93% 32 - 90% 10 - 70% 6 - 68% 23 - 65% 30 - 92% Solano et al, JPSM 2006; 31: 58-69
  • 19. Symptoms responsive to cannabinoids Pain Depression Anxiety Confusion (delirium) Fatigue Breathlessness (dyspnea) Nausea Constipation Anorexia
  • 20. What is the evidence? Pain Pre-clinical Clinical Evidence ++ +++
  • 21. Pre-clinical data: Pain Robust in vitro evidence cancer pain responds to cannabinoid treatment Use in bone pain/neuropathic pain has strongest evidence Direct use of agonists/antagonists and prevention of enzyme degradation Peripheral application effective, few A/E
  • 22. Clinical data: Pain Trial evidence supports oral use in cancer pain, in addition to usual therapy Small studies using smoking/vaporization None using edibles or oils Reduction in use of pain meds noted Few A/E
  • 23.
  • 24. Conclusions of reviews Studies small, short in duration, modest effect size “cannabinoids are safe, demonstrate a modest analgesic effect and provide a reasonable treatment option for chronic non-cancer pain”
  • 25. CPS neuropathic pain guideline revision Add additional agents sequentially if partial but inadequate pain relief Tramadol or Controlled-release opioid analgesic Fourth-line agents† Cannabinoids TCA Gabapentin or pregabalin SNRI ‡ †methadone, lamotrigine, topiramate, valproic acid, lidocaine. ‡Do not add SNRIs to TCAs Pain Res Manage 2014;19(6):328-335
  • 26. What is the evidence? Nausea Pre-clinical Clinical Evidence ++ +++
  • 27. Martin BR & Willey JL. J Support Onc 2004;2: 305-16 Cannabinoids in nausea
  • 28. CBs may be superior to conventional therapies in low- medium emetogenic setting Patient preference for CBs ranged from 38-90% (P 4-20%) CBs produced significantly more A/E effects (good & bad), more pt withdrawals “In selected patients, cannabinoids may be useful as mood enhancing adjuvants for the control of chemotherapy related sickness” BMJ 2001, 323:1-8
  • 29. Inhaled marijuana Three studies, associated with chemo administration Some new users, many previous cannabis users All studies showed benefit, but high incidence of side effects 25-35% pts prefer marijuana Vinciguerra et al, N Y State J Med 1988 88:525 Chang et al, Ann Int Med 1979 91:819 Levitt et al, JCO 1984 abstract C-354
  • 30. What is the evidence? Appetite/wt loss Pre-clinical Clinical Evidence ++ +
  • 31. Marijuana flips appetite switch in brain Sudden attacks of 'the munchies’ triggered by changes in hormone pro- opiomelanocortin (POMC) release by neurons doi:10.1038/nature.2015.16957 doi: 10.1038/nature14260
  • 32. Jatoi A et al. J Clin Oncol 2002;20:567-573 Nelson K et al. J Pall Care 1994;10:14-18 Timpone JG et al. AIDS Res Hum Retroviruses 1997;13:305-15 Struwe M et al. Ann Pharmacother 1993;27:827-31 Beal JE et al. J Pain Symptom Manage 1995;10:89-97 Beal JE et al. J Pain Symptom Manage 1997;14:7-14 Appetite and weight loss
  • 33. Dronabinol: taste alterations Pilot trial to improve taste, smell changes in advanced cancer patients THC 2.5 mg BID or TID vs placebo x 18 days, n=21 Questionnaires / interviews revealed significant improvement in taste / smell, increased appetite and protein intake QoL measures found improved relaxation, quality of sleep Adverse effects same in both groups TD Brisbois Clarkson et al, Ann Oncol 2011; 22: 2086-93
  • 34. What is the evidence? Neuroprotection Pre-clinical Clinical Evidence +/- +
  • 35.
  • 36. What is the evidence? Insomnia Pre-clinical Clinical Anxiety Pre-clinical Clinical Evidence - ++* ++ - *secondary finding
  • 37. Cannabinoids and anxiety Oral cannabinoids used for nausea produces sedation and reduces anxiety Very low dose cannabis can produce sedation, diminish anxiety without getting high Cannabidiol can exert anti-anxiety effects, although only demonstrated in acute, experimentally-induced anxiety Tramer et al, BMJ 2001; 323:1-8 Graham and Li, Cannabis and Health, 1976 Bergamaschi et al, Neuropsychopharmcol 2011; 36: 1219-26
  • 38.
  • 39. 20 Medical Studies That Prove Cannabis Can Cure Cancer http://www.collective-evolution.com/2013/08/23/20-medical-studies-that-prove- cannabis-can-cure-cancer/#sthash.H5ypYS6a.dpuf Cannabis Cures Cancer https://dl.dropboxusercontent.com/u/27713298/Web/cure/How_It_Works.html Run From The Cure: How Cannabis Cures Cancer And Why No One Knows Cannabis sativa hemp, the miracle plant, contains the cure for cancer and other ailments By Rick Simpson - Friday, March 7 2008 http://www.cannabisculture.com/articles/5169.html
  • 40. What is the evidence? Cancer Pre-clinical Clinical Clinical trials Evidence +++ nil - In Progress Cannabis is not a cure for cancer
  • 42. Prescription cannabinoids Dronabinol (Δ-9 tetrahydrocannabinol – THC) (2.5 - 10mg) Oral capsule Approved for chemotherapy-induced nausea and vomiting and anorexia associated with HIV/AIDS Nabilone (0.25 - 1.0mg) Oral capsule Approved for chemotherapy-induced nausea and vomiting Nabiximols (2.5mg THC + 2.7mg CBD) Oromucosal spray Approved in Canada for multiple sclerosis-associated neuropathic pain, spasticity and advanced cancer pain
  • 43. Female flowers (“buds”) are rich in cannabinoids (e.g. THC) Smoked Herbal cannabis-joints, pipes Vaporized Herbal cannabis heated to release cannabinoids but prevent burning Oral / buccal Tinctures (alcoholic extracts) Oils and edible products (cookies, brownies, etc.) Sublingual spray (nabiximols by prescription) Topical Balms, lotions and salves Medicinal cannabis products
  • 44.
  • 45. Health Canada website 36 Licensed Producers to date Patient confusion over who to choose What distinguishes one LP over another? Is the product safe? What does “Jack the Ripper” and “Green Kush” mean? Supply availability? http://www.hc-sc.gc.ca/dhp- mps/marihuana/info/list-eng.php
  • 46. Cannabis strains Thousands of cannabis strains exist 34 licensed producers listed >300 strains Most strains were developed for recreational use and still use common names high THC (15-20%), very low CBD (<1%) mod CBD (9-15%), low THC (1-4%) THC=CBD Oils (THC>CBD, THC=CBD, THC<CBD) Varying amounts of minor cannabinoids (CBC, THCV, etc.), terpenoids, flavonoids Page, 2014
  • 47. Medical cannabis: Is it different than street marijuana? Grown under strict Good Production Practices (GPP) guidelines enforced by Health Canada Most producers have industrial size “grow-ops” Products tested for microbials, mycotoxins, metals and pesticides Delivered to the patient in a safe and secure manner Concentrations of cannabinoids captured on label (usually THC and CBD) Recall ability given lot designation
  • 48. Precautions and contraindications Contraindications: Psychosis/schizophrenia Unstable heart disease Pregnancy Age under 21-25 (cognitive development) Ask about: History of legal issues/criminal charges Screening for other drug use Prior recreational cannabis use
  • 50. Patient Symptoms where conventional treatments have failed Compassionate end- of-life care or specified medical conditions Current ACMPR process
  • 51. PatientCompassionate end- of-life care or specified medical conditions A physician completes a medical document on behalf of patient for access to medicinal marijuana Current ACMPR process
  • 52. Patient Current ACMPR process The patient sends an application form to the Licensed Producer of their choice.
  • 53. Patient Current ACMPR process The Licensed Producer validates the client’s medical document / application form and adds them as a client. Once the client orders product, it is then shipped via secured courier to their door.
  • 54. Licensed Producer Mailing Address Product choice Health Care Practitioner Information Patient Information Written Order Physician Attestation, Signature
  • 55. Summary Cannabis & cannabinoids active in supportive care for cancer patients Clinical benefits in: pain, nausea, appetite More research is needed