Cappelli, C., Ragni, G., De Pasquale, M.D., Gonfiantini, M., Russo, D., & Clerico, A. (2005). Tropisetron: Optimal dosage for children in prevention of chemotherapy-induced vomiting. Pediatric Blood and Cancer, 45, 48–53. 

DOI Link

Study Purpose

To evaluate the efficacy of tropisetron in treating acute vomiting among children with solid tumors receiving chemotherapy

Intervention Characteristics/Basic Study Process

Tropisetron (5 mg for patients < 20 kg and 10 mg for patients > 20 kg) was given intravenously daily over 15 minutes 30 minutes before chemotherapy administration. No other antiemetics were given except for steroids in three patients with Hodgkin lymphoma and two patients with non-Hodgkin lymphoma. Data were collected hourly in the first 24 hours following chemotherapy.

Sample Characteristics

  • N = 50   
  • MEDIAN AGE = 5.8 years (range = 6 months to 19 years)
  • MALES: 27 (54%), FEMALES: 23 (46%)
  • KEY DISEASE CHARACTERISTICS: Central nervous system tumor, retinoblastoma, neuroblastoma, and chondrosarcoma (n = 30); Wilms tumor (n = 7); rhabdomyosarcoma (n = 4); Hodgkin disease (n = 3); non-Hodgkin lymphoma (n = 2); Ewing sarcoma (n = 2); and hepatoblastoma (n = 2)
  • OTHER KEY SAMPLE CHARACTERISTICS: All patients received either moderately or highly emetogenic chemotherapy.

Setting

  • SITE: Not stated
  • SETTING TYPE: Not specified    
  • LOCATION: Not reported

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Descriptive

Measurement Instruments/Methods

  • Antiemetic effects were monitored by nurses and patients.
  • Effects were classified as total control (TC, absence of acute vomiting), major control (MC, one to two acute vomiting episodes), or no control (NC, three or more acute vomiting episodes). 

Results

Overall frequency: TC was obtained in 154 out of 189 chemotherapy courses (85%), MC in 7.5% of courses, and NC in 7.5% of courses.

Dosage: Patients who received greater than 8 mg/m2 of tropisetron achieved TC significantly more often (92%) than patients receiving 6–8 mg/m2 of tropisetron (78%) or 6 mg/m2 (69%) (p = 0.0072).

Emetic potential: TC was achieved in 85% of patients receiving highly emetic chemotherapy, 81% of patients receiving moderately emetic chemotherapy, and 100% of patients receiving slightly emetic chemotherapy. NC was achieved in 6% of patients receiving highly emetic chemotherapy and 12% of patients receiving moderately emetic chemotherapy.  

Time of administration: TC was achieved in 91% of patients with initial chemotherapy while TC was achieved in 81% of patients who received an antiemetic medication for earlier chemotherapy (p > 0.05).

Age: The youngest age group (aged 0–5 years) achieved TC and MC 98% of the time while children aged 6–10 years achieved TC and MC 90.5% of the time and children aged greater than 10 years achieved TC and MC 84% of the time (p = 0.0235). Side effects of acute vomiting occurred immediately at the start of chemotherapy among one patient receiving tropisetron at 13.5 mg/m2

Conclusions

Tropisetron was an effective antiemetic medication for pediatric patients receiving highly emetic chemotherapy. It was mostly effective for patients receiving moderately emetic chemotherapy. The medication was more effective in younger children (aged 0–5 years). The dosage should range from 8–12 mg/m2 and be used with the initial chemotherapy course.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described

 

Nursing Implications

Tropisetron was an effective antiemetic medication that should be administered prior to the initial chemotherapy course.