Chang 1981.
Study characteristics | ||
Methods | Randomised, double‐blind, 3‐period cross‐over trial | |
Participants | 8 people (6/8 (75%) men/2/8 (25%) women) aged 17‐58 years (median = 41 years), 7/8 (88%) participants were cannabis naive Tumour types: resected soft tissue sarcoma Chemotherapy regimen: adjuvant doxorubicin and cyclophosphamide every 4 weeks until a total cumulative doxorubicin dose of 500‐550 mg/m2 Doxorubicin (70 mg/m2)and cyclophosphamide (700 mg/m2) were given at constant doses for all participants Chemotherapy emetogenicity: high |
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Interventions | Dronabinol 10 mg/m2 orally every 3 hours for total 5 doses, if vomited then participant given marijuana cigarettes 900 mg, containing THC 1.93% (approximately 17.4 mg), n = 8 Placebo, n = 8 |
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Outcomes | Episodes of nausea and vomiting on day of therapy | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Order of THC‐placebo administration was randomized into paired trials" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 17/27 (63%) participants received THC, 16/27 (59%) participants received placebo |
Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
Other bias | Unclear risk | Assumed washout period sufficient. Paired analysis was performed. Unclear if groups balanced at baseline |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Identical gelatin capsules with sesame oil. Identical cigarettes, the odour and taste of a lit placebo cigarette were identical to those of cannabis cigarette" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind". "Neither patients nor nursing staff was [sic] informed which drug was administered" |