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

NCT01913990 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2017-01-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Mark Clemons, Dr. · The Ottawa Hospital Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2017-08-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913990 on ClinicalTrials.gov