Study register · detailRCT (double-blind, parallel-group) · Palliative Care · 1979
Delta-9-tetrahydrocannabinol as an antiemetic for patients receiving cancer chemotherapy. A comparison with prochlorperazine and a placebo.
Frytak et al.·Annals of Internal MedicineImpact 4.3
MixedGRADEHigh202 citations
Samplen = 116 Pat.
ControlProchlorperazine 10 mg oral 3×/day or…
EndpointAntiemetic efficacy
Blindingdoppelblind
DesignRCT (double-blind, parallel-group)
Cannabinoidthc
Max. dose45.0 mg
Routeoral
”Key finding
THC reduced nausea/vomiting versus placebo, but offered no advantage over prochlorperazine and was associated with considerably more CNS side effects.
Summary
n=116 cancer patients undergoing chemotherapy, THC 15 mg 3x daily vs. prochlorperazine vs. placebo; THC showed superior antiemesis vs. placebo, no advantage over prochlorperazine; CNS side effects significantly more frequent/severe with THC; overall experience more burdensome for older patients (median age 61 years) with THC.
P
PopulationAdults (median 61 years) with gastrointestinal carcinoma under 5-fluorouracil/semustine chemotherapy, n=116
ControlProchlorperazine 10 mg oral 3×/day or placebo
O
OutcomeTHC superior to placebo in antiemetic effect, but no advantage over prochlorperazine; CNS side effects significantly more frequent and severe under THC
Confidence in the evidence
Very lowLowModerateHigh
High
The highest of four GRADE levels, the effect estimate is very reliable.
The antiemetic activity and side-effects of delta-9-tetrahydrocannabinol (THC) were evaluated in 116 patients (median age 61 years) receiving combined 5-fluorouracil and semustine (methyl CCNU) therapy for gastrointestinal carcinoma. In a double-blind study, patients were randomized to receive THC, 15 mg orally three times a day, prochlorperazine, 10 mg orally three times a day, or placebo. The THC had superior antiemetic activity in comparison to placebo, but it showed no advantage over prochlorperazine. Central nervous system side-effects, however, were significantly more frequent and more severe with THC. With the dosage and schedule we used, and in our patient population of largely elderly adults, THC therapy resulted in an overall more unpleasant treatment experience than that noted with prochlorperazine or placebo. Although THC may have a role in preventing nausea and vomiting associated with cancer chemotherapy, this role must be more clearly defined before THC can be recommended for general use.