Niiranen 1985.
Study characteristics | ||
Methods | Randomised, double‐blind, 2‐period cross‐over study | |
Participants | 32 people (20 men/4 women) aged 48‐78 years, mean = 61 years Tumour type: lung cancer Chemotherapy regimen: cyclophosphamide 1.2 g/m2 day 1, etoposide 150 mg/m2 IV day 1, 250 mg/m2 orally day 3, and vincristine 1.3 mg/m2 days 1 and 8 (5 people); cyclophosphamide 400 mg/m2, adriamycin 40 mg/m2, cisplatinum 40 mg/m2 every 28 days (8 people); cisplatinum 90 mg/m2 day 1 and vindesine 3 mg/m2 5 x weekly then twice monthly every 28 days (2 people); cisplatinum 90 mg/m2 day 1 and etoposide 50 mg/m2 days 1‐5 every 28 days (9 people); cisplatinum 60 mg/m2 day 1 and etoposide 150 mg/m2 IV day 1 and 200 mg/m2 orally day 3 every 28 days (1 person) Chemotherapy emetogenicity: high |
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Interventions | Nabilone 1 mg orally night before chemotherapy, 1 hour before chemotherapy and every 12 hours up to 24 hours as required orally, n = 32 Prochlorperazine 7.5 mg orally night before chemotherapy, 1 hour before chemotherapy and every 12 hours up to 24 hours as required orally, n = 32 |
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Outcomes | Episodes, frequency and severity of nausea and vomiting at 24 hours; withdrawal due to adverse effects; participant preference; episodes of drowsiness, hallucination, hypotension | |
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 | High risk | 24/32 (75%) participants received nabilone, 24/32 (75%) participants received prochlorperazine |
Selective reporting (reporting bias) | Low risk | Data reported for primary outcome |
Other bias | Unclear risk | Assumed washout period sufficient. 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 appearing capsules used" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding assumed as study reported as "double‐blind" and "identical appearing capsules used" |