Zick, S.M., Ruffin, M.T., Lee, J., Normolle, D.P., Siden, R., Alrawi, S., & Brenner, D.E. (2009). Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting. Supportive Care in Cancer, 17, 563–572.

DOI Link

Study Purpose

To evaluate the efficacy of ginger in relief of delayed chemotherapy-induced nausea and vomiting (CINV)

Intervention Characteristics/Basic Study Process

Patients with cancer who had experienced CINV during at least one previous round of chemotherapy were asked to participate. All participants were receiving a 5-HT3 receptor antagonist or aprepitant as part of their standard antiemetic regimen. Patients were randomized to receive either 1.0 g of ginger, 2.0 g of ginger, or matching placebo daily for three days.

Sample Characteristics

  • The study consisted of 162 participants.
  • The mean age was 55.7 years.
  • The majority of the participants was female.
  • Specific diagnoses were not stated.
  • Patients were receiving a variety of chemotherapy drugs of low, moderate, and high emetogenic risk.

Setting

The study was conducted at multiple outpatient settings in Ann Arbor, MI.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized double-blind, placebo-controlled trial.

Measurement Instruments/Methods

The Morrow Assessment of Nausea and Emesis (MANE) and the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 for Adverse Events were used.

Results

  • More than half (58%) of study participants reported experiencing both acute and delayed nausea; 30.9% reported acute vomiting or retching; and 24.7% reported delayed vomiting or retching.
  • No significant difference was found between either of the ginger doses compared to placebo in the terms of acute or delayed nausea or vomiting. This was consistent when participants were stratified by whether  aprepitant was prescribed as part of their CINV treatment.
  • Participants who received the higher dose of ginger (2.0 g) reported having significantly more severe episodes of delayed nausea compared to both placebo and low-dose ginger.

Conclusions

  • Ginger extract provided no benefit in reducing prevalence of delayed nausea and vomiting when added to standard contemporary antiemetic therapy.
  • When ginger was taken with aprepitant, prevalence of delayed vomiting was higher (although this did not reach statistical significance).

Limitations

  • The study lacked an adequate sample size.
  • Participants reported that they knew if they were randomized to either of the ginger treatment arms based on the taste of the capsule.

Nursing Implications

Ginger extract provides no clinical benefit at the doses evaluated when given in addition to standard, evidence-based medical therapy to prevent CINV. Ginger extract may have a negative effect on severity of nausea when taken with aprepitant.