Overview

This trial is active, not recruiting.

Condition emesis
Treatments dexamethasone, ondansetron, aprepitant, arm a: standard anti-emetic regimen
Phase phase 4
Sponsor Ottawa Hospital Research Institute
Start date September 2011
End date August 2014
Trial size 323 participants
Trial identifier NCT01913990, 2011348-01H

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
arm a: standard anti-emetic regimen
Treating physician's discretion for type of anti-emetic to be prescribed.
(Experimental)
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.
dexamethasone, ondansetron, aprepitant Decadron
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.

Primary Outcomes

Measure
Incidence of change in acute emesis (nausea and/or vomiting) in both study arms
time frame: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks

Secondary Outcomes

Measure
Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms
time frame: Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks

Eligibility Criteria

Female participants at least 19 years old.

Inclusion Criteria: Newly diagnosed invasive breast cancer (stage I-III) Scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy; Able to consent and fill study forms Exclusion Criteria: Received previous chemotherapy Symptoms of nausea or vomiting at baseline (disease related) On chronic anti-emetic therapy On daily corticosteroids prior to initiation of chemotherapy Allergic to steroids, 5HT3 or NK-1 Uncontrolled diabetes Medical or psychiatric illness that would interfere with patients' ability to complete the diary

Additional Information

Official title 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
Principal investigator Mark Clemons, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.