Emesis | Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.
Emesis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Dexamethasone, Ondansetron, AprepitantArm 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 regimenTreating physician's discretion for type of anti-emetic to be prescribed.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm A: Standard Anti-emetic regimenThe 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 B: Dexamethasone, Ondansetron, AprepitantThe 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.
Start Date: September 2011
Completed Date: December 2017
Phase: Phase 4
Primary Outcome: Incidence of change in acute emesis (nausea and/or vomiting) in both study arms
Secondary Outcome: Incidence of change in the delayed emesis (nausea and/or vomiting) in both study arms
Study sponsors, principal investigator, and references
Principal Investigator: Mark Clemons, Dr.
Lead Sponsor: Ottawa Hospital Research Institute