Chua 2000.
Study characteristics | ||
Methods |
Randomised, cross‐over trial with 3 arms
Recruitment period: March 1996 to May 1998
Masking: open‐label Baseline patient characteristics: reported Follow‐up: n.r. |
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Participants |
Inclusion criteria
Exclusion criteria
Median age (range), years: 48 (22 to 74) Gender: male (86.5%) + female (13.5 %) Tumour/cancer type: solid malignancy (nasopharynx, oral cavity, hypopharynx, larynx, ear) Chemotherapy regimen: cisplatin at a dose of 100 mg/m² on Day 1 and 5‐fluorouracil (5‐FU) 1000 mg/m² on Days 1 to 3, repeated every 21 days Country: Hong Kong, China |
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Interventions |
Cross‐over study: patients were randomised to receive 1 of the 3 5‐HT₃ antagonists in the first cycle; treatment was crossed over to the other 2 5‐HT₃ antagonists in the second and third cycles Experimental: arm A: granisetron granisetron 3 mg i.v. + dexamethasone 20 mg i.v. Experimental: arm B: tropisetron tropisetron 5 mg i.v. + dexamethasone 20 mg i.v. Experimental: arm C: ondansetron ondansetron 8 mg i.v. + dexamethasone 20 mg i.v. before cisplatin, followed by 2 p.o. doses of 8 mg at 4 and 8 hours after the start of chemotherapy on Day 1 |
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Outcomes |
Primary endpoint
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was performed using a computer‐generated code" |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not reported |
Blinding of participants and personnel (performance bias) Blinding of participants | High risk | Quote: "... open‐label ..." |
Blinding of participants and personnel (performance bias) Blinding of personnel | High risk | Quote: "... open‐label ..." |
Blinding of outcome assessment (detection bias) Subjective outcomes (Patient reported outcomes) | High risk | Comment: patients and personnel were not blinded towards the intervention and therefore might influence subjective outcomes analysis |
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes) | Low risk | Comment: all patients were included in the antiemetic efficacy analysis |
Selective reporting (reporting bias) | Low risk | Comment: all outcome measures were reported in the results section |
Other bias | Low risk | Comment: no information to suggest other sources of bias |