Study register · detailOpen-Label-Pilotstudie (zweiarmig) · Palliative Care · 2020
An Open-Label Pilot Study Testing the Feasibility of Assessing Total Symptom Burden in Trials of Cannabinoid Medications in Palliative Care.
Good et al.·Journal of Palliative MedicineImpact 1.0
MixedGRADELow40 citations
Samplen = 21 Pat.
Duration28 days
EndpointESAS
Blindingoffen
DesignOpen-Label-Pilotstudie (zweiarmig)
Cannabinoidkombination
Max. dose600.0 mg
Routeoral
”Key finding
Cannabinoids (CBD/THC) were predominantly well tolerated and led to a relevant symptom reduction in 43% of palliative patients, however without a control group and with a high dropout rate by day 28.
Summary
Pilot trial n=21 palliative patients with advanced cancer (CBD arm n=16, THC arm n=5); 9/21 (43%) achieved clinical response (≥6-point reduction TSDS); median maximum tolerated dose CBD 300 mg/day (range 100–600 mg), THC 10 mg/day (range 5–30 mg); 86% completed primary endpoint on day 14; drowsiness most common adverse event — feasibility study with limited informative value.
P
PopulationAdults with advanced cancer and cancer-related symptoms in palliative and supportive care (Australian cancer centre), n=21
I
InterventionEscalating CBD oil (up to max. 600 mg/day) or THC oil (up to max. 30 mg/day), oral, two arms (CBD n=16, THC n=5)
O
Outcome86% (18/21) participants completed primary endpoint on day 14; 43% (9/21) showed response (≥6-point reduction in TSDS); median maximum tolerated doses: CBD 300 mg/day, THC 10 mg/day
Confidence in the evidence
Very lowLowModerateHigh
Low
The second of four GRADE levels, the effect estimate is of limited reliability.
<b><i>Background:</i></b> 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. <b><i>Objectives:</i></b> 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). <b><i>Design:</i></b> Prospective two-arm open-label pilot trial of escalating doses of CBD and THC oil. <b><i>Setting/Subjects:</i></b> Participants had advanced cancer and cancer-related symptoms in a palliative and supportive care service in an Australian cancer center. <b><i>Measurements:</i></b> 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. <b><i>Results:</i></b> Of the 21 participants enrolled (CBD, <i>n</i> = 16; THC, <i>n</i> = 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. <b><i>Conclusions:</i></b> 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.