drugset / Trial / NCT01913990

Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.

NCT01913990 ↗

Phase 4 Unknown 323 enrolled Ottawa Hospital Research Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. The risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.

Timeline

Start
2011-09
Primary completion
2017-08
Completion
2017-12

Outcome

Met primary endpoint

paper significantly more patients in the RMG group reported no nausea (53.7% [95% CI, 49.2%-58.1%] vs 41.6% [95% CI, 37.4%-45.3%]; P < .001) PMID 26562292 ↗

paper Similarly, significantly more patients in the RMG group reported no nausea (39.6% [95% CI, 35.3%-44.1%] vs 30.7% [95% CI, 26.8%-34.7%]; P = .01) PMID 26562292 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified — —
Subject Dexamethasone Small molecule — —
Subject Ondansetron Other / unclassified — —

Indications

No indication recorded.