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A randomized, prospective, open-label, controlled trial comparing the efficacy of omitting H2 antagonists versus famotidine in premedication protocol for prophylaxis of taxane hypersensitivity reactions

A randomized, prospective, open-label, controlled trial comparing the efficacy of omitting H2 antagonists versus famotidine in premedication protocol for prophylaxis of taxane hypersensitivity reactions

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220913005
Enrollment
140
Registered
2022-09-13
Start date
2022-09-19
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A randomized, prospective, open-label, controlled trial comparing the efficacy of omitting H2 antagonists versus famotidine in premedication protocol for prophylaxis of taxane hypersensitivity reactions A randomized, prospective, open-label, controlled trial comparing the efficacy of omitting H2 antagonists versus famotidine in premedication protocol for prophylaxis of taxane hypersensitivity reactions

Interventions

Schedule of modified premedication without H2 antagonist protocol 1.Dexamethasone 20 mg intravenous 2.Ondansetron 8 mg oral 3.Diphenhydramine 50 mg oral 4.CPM 10 mg intravenous,Schedule of standard pr
modified premedication without H2 antagonist protocol,famotidine premedication protocol

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Cancer patients who received taxane chemotherapy regimen

Exclusion criteria

Exclusion criteria: 1.History of severe Hypersensitivity reactions from taxane regimen 2.Severe hepatic impairment (bilirubin >5xULN or AST/ALT >10xULN) 3. Patients with a history of severe hypersensitivity reactions to taxanes such as bronchospasm, hypotension.

Design outcomes

Primary

MeasureTime frame
Hypersensitivity reactions every 3 week of six-cycle course of chemotherapy grading of Hypersensitivity reactions

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactChaichana Chantharakhit

Division of Medical Oncology, Department of Medicine, Buddhasothorn Hospital, Chachoengsao, Thailand

chaichana.md@gmail.com0817866945

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026