Clemons, M., Bouganim, N., Smith, S., Mazzarello, S., Vandermeer, L., Segal, R., . . . Dranitsaris, G. (2016). Risk model-guided antiemetic prophylaxis vs physician's choice in patients receiving chemotherapy for early-stage breast cancer: A randomized clinical trial. JAMA Oncology, 2, 225–231. 

To test the clinical utility of a chemotherapy-induced nausea and vomiting (CINV) risk model to improve patient outcomes compared to usual care

Patients were randomly assigned to the risk model group (RMG) or physician choice group (PCG) (control). Those in the RMG group had acute and delayed emetic risk scores calculated prior to each cycle of chemotherapy. Patients with low risk (acute risk score < 7, delayed score ≤ 16) received dexamethasone and ondansetron regimens. Those at high risk by the models were given triplet antiemetics according to highly emetogenic chemotherapy (HEC) guidelines. Patients assigned to the PCG were given whatever regimen their oncologist decided upon. Patients rated their control of nausea and vomiting on a 4-point Likert-type scale, and need for intravenous fluids was recorded. Patients were contacted by phone on days 1 and 5 after chemotherapy.

• N = 312   
• MEAN AGE = 53.6 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving either four cycles of AC (doxorubicin and cyclophosphamide) or three cycles of FEC (5-fluorouracil, epirubicin, and cyclophosphamide) or FAC (5-fluorouracil, doxorubicin, and cyclophosphamide). A total of 1,184 cycles were included in the study.
• OTHER KEY SAMPLE CHARACTERISTICS: The groups were similar in terms of cancer stage, history of motion sickness, alcohol intake history, and comorbid conditions.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Canada

• PHASE OF CARE: Active antitumor treatment

• Randomized controlled trial (RCT)

• 4-point Likert-type scales for nausea and vomiting
• 4-point scale for severity of IV fluid need from none to requiring hospitalization
• Functional Living Index-Emesis (FLIE)

In cycle 1, 94.1% in the PCG group and 15.6% in the RMG group were given 5-HT₃ and dexamethasone prophylaxis, and 81.2% in the RMG group and 4.1% of controls were given triple drug regimens. In the RMG group, 90% received aprepitant by cycle 4 and 40% had olanzapine added to cycles 3 and 4. In the control group, aprepitant was added to about 25% of cycles 2–4. Significantly fewer patients in the RMG group required prochlorperazine (p = 0.02) or methotrimeprazine (p = 0.001) for rescue. No differences existed in the need for IV fluids between groups. In both the acute and delayed phases, significantly more patients in the RMG group reported no vomiting and no nausea (p < 0.001). FLIE scores were consistently better in the RMG group, but differences from control patients were not statistically significant.

The use of the emetic risk model for prophylaxis decision making was shown to be more effective than physician antiemetic choice for the prevention of both acute and delayed CINV.

• Risk of bias (no blinding)
• Measurement validity/reliability questionable
• Likert-type scales used were not previously tested.

The findings support the use of emesis risk prediction in treatment decision making for antiemetic prophylaxis. Nurses can advocate for the consideration of emetic risk and the appropriate prescription of antiemetics for patients with breast cancer receiving chemotherapy.