PMID- 31800354
OWN - NLM
STAT- MEDLINE
DCOM- 20210618
LR  - 20210618
IS  - 1557-7740 (Electronic)
IS  - 1096-6218 (Print)
IS  - 1557-7740 (Linking)
VI  - 23
IP  - 5
DP  - 2020 May
TI  - An Open-Label Pilot Study Testing the Feasibility of Assessing Total Symptom 
      Burden in Trials of Cannabinoid Medications in Palliative Care.
PG  - 650-655
LID - 10.1089/jpm.2019.0540 [doi]
AB  - Background: There is considerable interest in the use of cannabinoids for symptom 
      control in palliative care, but there is little high-quality evidence to guide 
      clinical practice. Objectives: Assess the feasibility of using global symptom 
      burden measures to assess response to medicinal cannabis, to determine median 
      tolerated doses of cannabidiol (CBD) and tetrahydrocannabinol (THC), and to 
      document adverse events (AEs). Design: Prospective two-arm open-label pilot trial 
      of escalating doses of CBD and THC oil. Setting/Subjects: Participants had 
      advanced cancer and cancer-related symptoms in a palliative and supportive care 
      service in an Australian cancer center. Measurements: The main outcome measures 
      were the number of participants screened and randomized over the time frame, the 
      number of participants completing days 14 and 28 and providing total symptom 
      distress scores (TSDSs) (measured using the Edmonton Symptom Assessment Scale), 
      and the change from baseline of the TSDS at day 14. Results: Of the 21 
      participants enrolled (CBD, n = 16; THC, n = 5), 18 (86%) completed the primary 
      outcome measure at day 14 and 8 completed at day 28. The median maximum tolerated 
      doses were CBD, 300 mg/day (range 100-600 mg); THC, 10 mg/day (range 5-30 mg). 
      Nine of 21 patients (43%) met the definition of response (>/=6 point reduction in 
      TSDS). Drowsiness was the most common AE. Conclusions: Trials of medicinal 
      cannabis in advanced cancer patients undergoing palliative care are feasible. The 
      doses of THC and CBD used in this study were generally well tolerated and the 
      outcome measure of total symptom distress is promising as a measure of overall 
      symptom benefit. Trial registration: ACTRN12618001205224.
FAU - Good, Phillip D
AU  - Good PD
AD  - Department of Palliative and Supportive Care, Mater Misericordiae, Ltd., 
      Brisbane, Queensland, Australia.
AD  - Mater Research University of Queensland, South Brisbane, Queensland, Australia.
AD  - Department of Palliative Care, St. Vincent's Private Hospital, Brisbane, 
      Queensland, Australia.
FAU - Greer, Ristan M
AU  - Greer RM
AD  - Mater Research University of Queensland, South Brisbane, Queensland, Australia.
FAU - Huggett, Georgina E
AU  - Huggett GE
AD  - Department of Palliative and Supportive Care, Mater Misericordiae, Ltd., 
      Brisbane, Queensland, Australia.
AD  - Mater Research University of Queensland, South Brisbane, Queensland, Australia.
FAU - Hardy, Janet R
AU  - Hardy JR
AD  - Department of Palliative and Supportive Care, Mater Misericordiae, Ltd., 
      Brisbane, Queensland, Australia.
AD  - Mater Research University of Queensland, South Brisbane, Queensland, Australia.
LA  - eng
SI  - ANZCTR/ACTRN12618001205224
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191203
PL  - United States
TA  - J Palliat Med
JT  - Journal of palliative medicine
JID - 9808462
RN  - 0 (Cannabinoids)
SB  - IM
MH  - Australia
MH  - *Cannabinoids
MH  - Feasibility Studies
MH  - Humans
MH  - *Palliative Care
MH  - Pilot Projects
MH  - Prospective Studies
PMC - PMC7232640
OTO - NOTNLM
OT  - cancer
OT  - cannabidiol
OT  - cannabis
OT  - palliative care
OT  - symptom control
OT  - tetrahydrocannabinol
COIS- No competing financial interests exist.
EDAT- 2019/12/05 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/05/04
CRDT- 2019/12/05 06:00
PHST- 2019/12/05 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2019/12/05 06:00 [entrez]
PHST- 2020/05/04 00:00 [pmc-release]
AID - 10.1089/jpm.2019.0540 [pii]
AID - 10.1089/jpm.2019.0540 [doi]
PST - ppublish
SO  - J Palliat Med. 2020 May;23(5):650-655. doi: 10.1089/jpm.2019.0540. Epub 2019 Dec 
      3.