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NK1 Receptor Antagonist

Arm B: Dexamethasone, Ondansetron, Aprepitant for Vomiting (ER11-02 Trial)

Phase 4
Waitlist Available
Led By Mark Clemons, Dr.
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
Awards & highlights

ER11-02 Trial 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.

Eligible Conditions
  • Vomiting

ER11-02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of change in acute emesis (nausea and/or vomiting) in both study arms
Secondary outcome measures
Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms
Other outcome measures
Difference in breakthrough anti-emetic use in the emesis risk model group compared to the standard arm; i.e.: requirements for additional oral and parenteral anti-emetics during a single chemotherapy cycle

ER11-02 Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Dexamethasone, Ondansetron, AprepitantExperimental Treatment1 Intervention
The emesis risk model arm: Prior to the start of intravenous chemotherapy an emesis risk score will be calculated for both acute and delayed emesis. The anti-emetic prophylaxis treatment will follow the emesis risk score. Whereby either an acute emesis score of ≥7 and/or a delayed emesis score of >16 will be considered high-risk. The anti-emetics will be prescribed reflecting this risk for pre-chemotherapy, 8 hrs post chemotherapy and day 2-3 post chemotherapy. Dexamethasone, Ondansetron and Aprepitant will be given in different combination and doses depending on what score the participant receives based on their responses to the diary. For subsequent cycle the anti-emetic score will be re-calculated prior to each cycle and the choice of anti-emetics adjusted if necessary.
Group II: Arm A: Standard Anti-emetic regimenExperimental Treatment1 Intervention
The standard anti-emetic arm: In this arm the treating medical oncologist will determine the choice of anti-emetic regimen that they perceive the patient would require and prescribe it. The treating physician will be blinded to result of the personalized composite emesis score. The physician may or may not choose to prescribe an NK-1 inhibitor as the study will not predetermine the type of anti-emetics used. In the event that the patient experienced chemo induced nausea and vomiting (CINV), modifications to the initial anti emetic regimen would be left to the treating physician.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,371 Total Patients Enrolled
3 Trials studying Vomiting
6,551 Patients Enrolled for Vomiting
Mark Clemons, Dr.Principal InvestigatorThe Ottawa Hospital Cancer Centre
1 Previous Clinical Trials
74 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.
2011. "Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01913990.
~24 spots leftby Apr 2025
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