NCT01913990

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

A Randomized, Phase IV Trial of Individualized Care Versus Standard Care, in the Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. The EPIC Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 323 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emesis

Interventions

Type	Name	Description
DRUG	Dexamethasone, Ondansetron, Aprepitant	Arm B participants will be given doses of anti-emetics based on the emesis risk calculation. Doses will vary depending on the which level they fall into level 0, level 1, 2 or 3 based on the participant's diary.
OTHER	Arm A: Standard Anti-emetic regimen	Treating physician's discretion for type of anti-emetic to be prescribed.

Timeline

• Start date: 2011-09-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2013-08-01
• Last updated: 2017-01-30

Locations

1 site across 1 country: Canada