Lorusso, V., Giampaglia, M., Petrucelli, L., Saracino, V., Perrone, T., & Gnoni, A. (2012). Antiemetic efficacy of single-dose palonosetron and dexamethasone in patients receiving multiple cycles of multiple day-based chemotherapy. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 20, 3241–3246.

DOI Link

Study Purpose

To assess the efficacy of a single dose of palonosetron and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) and guarantee an adequate food intake in patients receiving several cycles of multiple-day-based chemotherapy

Intervention Characteristics/Basic Study Process

Patients with advanced cancer but without a compromised nutritional status (bone mass > 18.5) receiving multiple cycles of multiple days (MD-CT) were treated with 0.25 mg palonosetron over 30 seconds and 20 mg dexamethasone 30 minutes prior to chemotherapy. Patients recorded the number and intensity of emesis episodes, use of rescue medication, and the time and amount of daily food intake including pictures when available.

Sample Characteristics

  • The study consisted of 50 patients, none of whom were severly malnourished.
  • The median age was 56.8 years.
  • The sample was 18% male and 82% female.
  • Cancer diagnoses were sarcoma (52%), cervix (34%), bladder (6%), breast (6%), and lung (2%).
  • The majority of patients (74%) were chemotherapy naïve.
  • Patients had normal renal and liver function, no uncontrolled vomiting, and no intestinal obstruction, peritonitis, serious mucositis, or infections.

 

Setting

This study was conducted at a single site at a hospital in Lecee, Italy.

Phase of Care and Clinical Applications

  • Patients were in active treatment.
  • This study has application to elderly care.

Study Design

This was a prospective, uncontrolled trial.

Measurement Instruments/Methods

  • Patients recorded complete response (CR), defined as no vomiting and no use of rescue medications, in diaries.
  • Patients quoted their daily food intake, the time food was consumed, and the amount of each portion eaten. Amount were quantified using pictures of standard portions included in the diary.  
  • Diaries had to be completed from day 1 to the end of day 7 (168 hours postchemotherapy).

Results

  • During the 6 cycles, CR ranged from 76%–88%.
  • Complete Control (CC), defined as no vomiting, no rescue medication, and no more than mild nausea, ranged from 62%–88%.
  • Total Control (TC), defined as no vomiting, no rescue medication, and no nausea, ranged from 54%–80%.
  • The correlation between severity of nausea and the amount of food intake remained uniform during all cycles.  Patients with CR had a significant higher weekly food intake than those using rescue medication or vomiting.
  • Patients who experienced CC and no nausea had a median weekly for intake ranging from 11,102–12,200 kcal compared to patients with CC, but patients with mild nausea had a lower median weekly food intake.

Conclusions

  • A single dose of palonosetron and dexamethasone were shown to be effective in prevention of vomiting and nausea in patients receiving multiple day-based chemotherapy and the effectiveness last over six cycles.
  • The use of dexamethasone was limited to day one, which may eliminate steroid side effects over multiple cycles.
  • A direct correlation was found between severity of nausea and weekly caloric intake. Even mild nausea caused a decrease in kcal consumed between 2,102 to 2,957.  This was maintained across all six cycles.
     

Limitations

  • The sample size was small with fewer than 100 patients.
  • Large and randomized studies are needed to assess the role of CINV on food intake in both multiple-day and single-day chemotherapy.  
  • Why aprepitant was not used for this highly emetogenic combination of chemotherapy agents is not known as aprepitant is indicated in Oncology Nursing Society (ONS), National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines in combination with a 5-HT3 and steriod.

Nursing Implications

A direct correlation exists between mild nausea and significant decrease in food intake. Patients can easily become malnourished. Nurses need to assess closely for nausea, using a Likert-type scale and weight loss and malnutrition.

Palonosetron and dexamethasone can achieve high control of CINV during multiple days and multiple cycles of HEC. Nurses need to use instruments like the subjective global assessment (SGA) used in this study to better identify patients at risk for malnourishment rather than reyling solely on body mass index (BMI).