An open-label randomized controlled trial to evaluate the efficacy of antihistamine premedication and infusion prolongation in prevention of hypersensitivity reaction to oxaliplatin.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210506001

Enrollment

160

Registered

2021-05-06

Start date

2020-07-01

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

Hypersensitivity reaction (HSR) is a common toxicity associated with oxaliplatin. Oxaliplatin is a chemotherapy mainly used in gastrointestinal malignancies especially colorectal cancer. The incidences of oxaliplatin induced HSR vary from 12% to 25% (1-5) (6-8) (9, 10). Although it is usually mild to moderate severity (11), it could be severe (9, 10) and result in treatment discontinuation. Oxaliplatin induced HSR is a type I hypersensitivity. It usually occurs in later cycles of treatment

Interventions

Additional intravenous chlorpheniramine 10 mg at 30 minutes before oxaliplatin infusion and oxaliplatin was given in a 3-hour intravenous infusion for all 6 planned cycles of FOLFOX/FOLFIRINOX regimen

Experimental Drug,Active Comparator Drug

CPM + prolongation oxaliplatin infusion ARM,Controlled ARM

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Eligible patients were 18 years of age or older, diagnosed with gastrointestinal cancer and receiving oxaliplatin based chemotherapy including FOLFOX (Fluorouracil, Leucovorin and Oxaliplatin), FOLFIRINOX (Fluouracil, Leucovorin, Irinotecan and Oxaliplatin) or CAPOX (capecitabine and Oxaliplatin). All patients had completed 6 cycles of FOLFOX/FOLFIRINOX or 4 cycles of CAPOX , and plan to receive 6 or 4 more cycles of FOLFOX/FOLFIRINOX or CAPOX , respectively. Patients were in Eastern Cooperative Oncology Group performance-status score of 0 or 2 and had adequate organ function.

Exclusion criteria

Exclusion criteria: The patients with history of oxaliplatin hypersensitivity and currently receiving antihistamine were excluded. Written informed consent was obtained from all patients.

Design outcomes

Primary

Measure	Time frame
incidence of hypersensitivity reaction during oxaliplatin infusion number of event, grade	—

Secondary

Measure	Time frame
N/A N/A N/A	—

Countries

Thailand

Contacts

Public ContactChalita Lagampan

Chulalongkorn University.

zenith_nna@hotmail.com66892018454

Outcome results

None listed

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