Dranitsaris, G., Mazzarello, S., Smith, S., Vandermeer, L., Bouganim, N., & Clemons, M. (2016). Measuring the impact of guideline-based antiemetic therapy on nausea and vomiting control in breast cancer patients with multiple risk factors. Supportive Care in Cancer, 24, 1563–1569. 

DOI Link

Study Purpose

The purpose of this study was to determine if guideline-based antiemetic therapy would improve chemotherapy-induced nausea and vomiting (CINV) in patients with multiple risk factors for CINV

Intervention Characteristics/Basic Study Process

Patients were randomized to the risk model-guided antiemetic therapy group or a physician’s choice antiemetic group. All patients in the physician’s choice group received antiemetics at a dose and frequency chosen by the physician. Patients in the risk model-guided antiemetic therapy group were stratified into low-risk or high-risk categories based on a risk model developed in a previous study.
 
Low-risk patients (level 0) received the following.
Day 1: 10 mg dexamethasone IV and 8 mg ondansetron by mouth (PO) prior to chemotherapy and 4 mg dexamethasone PO and 8 mg ondansetron PO eight hours after chemotherapy
Days 2 and 3: 4 mg dexamethasone PO two times a day (BID) and 8 mg ondansetron PO BID
 
High-risk patients (level 1) received the following.
Day 1: 12 mg dexamethasone IV, 8 mg ondansetron PO, and 25 mg aprepitant PO prior to chemotherapy, and 8 mg ondansetron eight hours after chemotherapy
Days 2 and 3: 80 mg aprepitant PO daily
 
Additional dexamethasone and olanzapine 2.5 mg daily for seven days were added to subsequent cycles for patients with poorly controlled CINV (levels 2 and 3).

Sample Characteristics

  • N = 152 
  • AGE RANGE = 26–76 years
  • MEDIAN AGE = 54 years
  • MALES (%): Not provided, FEMALES (%): Not provided
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Early-stage breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Anthracycline-based chemotherapy

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized controlled trial (RCT)

Measurement Instruments/Methods

  • The Functional Living Index-Emesis (FLIE) was used to measure the impact of CINV on the patients' quality of life. This assessment was given to patients on day 5.
  • Patients used a diary daily to record the frequency, intensity, and duration of CINV. This diary was used for the first five days post administration of chemotherapy. The research nurse called the patient on days 1 and 5.

Results

In the first 24 hours post chemotherapy, the proportion of patients in each risk level who experienced vomiting was similar; however, acute nausea was more common in the high-risk patients, with patients in levels 1–3 being 2–4 times more likely to experience nausea than patients in level 0. Delayed vomiting was similar among the different levels of patients, but delayed nausea was more common in higher risk patients. The highest risk patients (level 3) were eight times more likely to experience delayed nausea than the lowest risk patients (level 0) (odds ratio [OR] = 8, p < 0.001). Delayed nausea was highest after the cycle 1 of chemotherapy.
 
Quality of life related to vomiting was similar in patients from each risk level, but quality of life related to nausea was significantly different between risk levels when compared to level 0 (level 1: p = 0.023, level 2: p = 0.007, level 3: p = 0.005).

Conclusions

Patients from all risk levels had similar rates of acute and delayed vomiting; however, acute and delayed nausea remained higher in the high-risk patients.

Limitations

  • Findings not generalizable
  • No report of comparison of outcomes across study groups

Nursing Implications

By assessing patient risk factors for CINV and prescribing antiemetic therapy based on patient risk stratification, acute and delayed vomiting may be managed; however, acute and delayed nausea remained significantly higher in the highest risk patients.