Kluin‐Neleman 1979.
Study characteristics | ||
Methods | Randomised, double‐blind, 2‐period cross‐over study | |
Participants | 11 people (10 men/1 woman) aged 21‐53 years Tumour types: Hodgkin's or non‐Hodgkin's lymphoma Chemotherapy regimens: mitoxine 6 mg/m2 (maximum 10 mg), vincristine 1.4 mg/m2 (maximum 2 mg) IV on days 1 and 8. Procarbazine 100 mg/m2 and prednisone 40 mg/m2 oral days 1‐14 for 6 cycles with intervals of 2 weeks Chemotherapy emetogenicity: high |
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Interventions | Dronabinol 10 mg/m2 orally, n = 11 Placebo, n = 11 |
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Outcomes | Episodes of nausea and vomiting at end of day of therapy, feeling high, dizziness, hallucinations | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 17 participants received THC, 11 participants received placebo |
Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
Other bias | Unclear risk | Washout period 2 weeks. Unclear if paired analysis was performed. Unclear if groups were balanced at baseline |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Identical gelatin capsules were used" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind" and "identical gelatin capsules used" |