Chang 1979a.
Study characteristics | ||
Methods | Randomised, double‐blind, 3‐period cross‐over, placebo‐controlled trial | |
Participants | 15 people (10/15 (67%) men/5/15 (33%) women) aged 15‐49 years (median = 24 years). 4/15 (27%) participants were cannabis naive Tumour type: osteogenic sarcoma Chemotherapy regimens: methotrexate 250 mg/kg with leucovorin calcium rescue every 3 weeks for 18 months Chemotherapy emetogenicity: low |
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Interventions | Dronabinol 10 mg/m2 orally every 3 hours for total 5 doses (Phase I), n = 15. If participant vomited during this period oral dose was replaced with THC cigarette for remaining doses Placebo, n = 15 |
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Outcomes | Episodes of nausea and vomiting on day of therapy; frequency and severity of nausea; episodes of sedation, euphoria, dizziness, depression, paranoia | |
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 three paired trials" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 58/77 (75%) participants received THC, 39/53 (74%) participants received placebo |
Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
Other bias | Low risk | 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" |