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

Phase 4

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm B: Dexamethasone, Ondansetron, Aprepitant	Dexamethasone, Ondansetron, Aprepitant	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.

Primary Outcome Measures

Name	Time	Method
Incidence of change in acute emesis (nausea and/or vomiting) in both study arms	Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks	The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines.

Secondary Outcome Measures

Name	Time	Method
Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms	Prior to each chemotherapy cycle every 3 weeks, at 24hrs post chemotherapy and at day 6 post chemotherapy for a total of 12 weeks	The modified FLIE questionnaire is a patient-reported measure of the impact of chemotherapy induced emesis on daily life. It is a short, self administered instrument containing two domains-one for nausea (9 items) and one for vomiting (9 items). The modified FLIE questionnaire will be administered before the initiation of chemotherapy and on days 1 and 6, and prior to each cycle while on study. Responses to each question are scored on a 1- to 7-point scale as described in the FLIE Scoring Manual. For this study, "minimal or no impact of CINV on daily life" is defined as an average score of more than 6 on the 7-point scale. Additional data will be collected to assess physician anti-emetic prescribing habits as compared to published guidelines.