Skip to main content
. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

Chua 2000.

Study characteristics
Methods Randomised, cross‐over trial with 3 arms
  • comparison of granisetron + dexamethasone vs tropisetron + dexamethasone vs ondansetron + dexamethasone


Recruitment period: March 1996 to May 1998
  • 94 patients recruited

  • 89 patients included in analysis


Masking: open‐label
Baseline patient characteristics: reported
Follow‐up: n.r.
Participants Inclusion criteria
  • age ≥ 18 years

  • chemotherapy‐naïve patients who were to receive at least 3 cycles of high‐dose cisplatin (100 mg/m²)

  • ECOG performance status 0 to 2

  • no significant cardiac, hepatic, or renal disease


Exclusion criteria
  • gastrointestinal obstruction, brain tumour, increase in intracranial pressure, or pre‐existing nausea or vomiting


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
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
Outcomes Primary endpoint
  • proportion of patients with complete (no nausea or vomiting, or mild nausea only in the 24 h after the start of chemotherapy) or major (single vomiting episode in the 24 h after the start of chemotherapy, or no vomiting but moderate to severe nausea) response

Notes
  • "supported by grants from the University of Hong Kong (CRCG grant no. 337/037/0001, 335/037/0001, and 335/037/0002)"

  • study authors did not provide disclosure of potential conflicts of interest

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