Yang, L.Q., Sun, X.C., Qin, S.K., Chen, Y.X., Zhang, H.L., Cheng, Y., . . . Yu, S.Y. (2016). Transdermal granisetron for the prevention of nausea and vomiting following moderately or highly emetogenic chemotherapy in Chinese patients: A randomized, double-blind, phase III study. Chinese Clinical Oncology, 5, 79. 

DOI Link

Study Purpose

To compare the efficacy and tolerability of transdermal granisetron to oral granisetron

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either a granisetron patch and placebo capsules or a placebo patch and granisetron capsules. Samples were stratified according to emetogenicity of chemotherapy, gender, and chemotherapy duration. Patches were applied for 24-48 hours before chemotherapy and left in place for seven days. Patients received 1 mg oral medication one to two hours before chemotherapy and then 1 mg every 12 hours throughout chemotherapy.

Sample Characteristics

  • N = 313   
  • MEDIAN AGE = 59 years, 57 years
  • MALES: 61%, FEMALES: 30%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Varied tumor types—lung and gastrointestinal were most common.
  • OTHER KEY SAMPLE CHARACTERISTICS: About one-third were chemotherapy naive.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Double-blind, placebo-controlled, parallel group trial

Measurement Instruments/Methods

  • Complete control (CC): no vomiting or retching, no rescue medication, and no more than mild nausea
  • Time to failure of CC
  • Complete response (CR): no vomiting or retching, no use of rescue medication

Results

More patients in the oral granisetron group achieved CC (58.97% versus 46.75%, p = 0.04). The biggest difference occurred on the first day of chemotherapy. From days 2–5, no significant difference existed between groups. There were no differences based on gender, age, or emetogenicity of the chemotherapy regimen. More patients taking oral granisetron reported constipation.

Conclusions

In this study, oral granisetron was more effective than transdermal granisetron for control of chemotherapy-induced nausea and vomiting (CINV) during the acute phase.

Limitations

  • Measurement/methods not well described
  • Documentation of CINV episodes was not described.
  • Other antiemetics recommended for highly and moderately emetogenic chemotherapy were not used.

Nursing Implications

In this study, oral granisetron was more effective for CINV prevention than transdermal granisetron during the acute phase. In the delayed phase, results were similar for both interventions. It is unclear if the timing of application of the transdermal medication may affect this finding.