Lajolo, P.P., De Camargo, B., & Del Giglio, A. (2009). Omission of day 2 of antiemetic medications is a cost saving strategy for improving chemotherapy-induced nausea and vomiting control results of a randomized phase III trial. American Journal of Clinical Oncology, 32, 23–26. 

To evaluate the effect of omitting day 2 administration of granisetron in the treatment of chemotherapy-induced nausea and vomiting (CINV)

• All patients received 16 mg IV ondansetron, 20 mg dexamethasone, and 50 mg ranitidine before highly or moderately emetogenic chemotherapy on day 1.
• On day 2, all patients received 10 mg metoclopramide, every 8 hours on days 2, 3, and 4; 8 mg dexamethasone daily on days 2 and 3; and 150 mg ranitidine every 12 hours.
• Patients were randomly assigned to receive either 0.5 mg granisetron on days 2 and 3 or placebo instead of granisetron on day 2 and 0.5 mg granisetron on days 3 and 4.
• Patients recorded emetic episodes and side effects of antiemetic medications in self-report diaries, which were evaluated on day 6.

• The study consisted of 73 participants.
• Mean age was 51.4 years.
• The majority (94%) of patients were female.
• The majority (95%) of patients had breast cancer.
• The majority were receiving chemotherapy containing 60 mg/m² doxorubicin.
• Nearly half (49%) of patients had previously experienced complete protection in the first cycle of chemotherapy at baseline.

The study was conducted at a single outpatient setting in Brazil.

All patients were in active treatment.

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

• Emesis was measured using the Functional Living Index-Emesis (FLIE).
• Complete protection was defined as absence of any episode of nausea or vomiting.

• A higher proportion of patients in the experimental group experienced complete protection from nausea and vomiting (p = 0.046) in the acute phase.
• No significant differences were found between groups in FLIE scores or proportions of patients who achieved complete protection from nausea and vomiting in other treatment phases.
• No differences were found between groups in adverse events.

Differences in rates of complete protection from nausea and vomiting in this study were unclear and difficult to interpret because different groups experienced better CINV control at different time points.

• The sample had fewer than 100 participants.
• Although the authors concluded that elimination of one dose of granisetron resulted in better control, the actual results reported did not appear to support that conclusion.
• It was also unclear how the two groups truly differed, other than the timing of the medication, because the “control” group received granisetron on the same number of days in the treatment cycle.
• Measurement depended on patient diaries; however, overall compliance rate with diaries was not reported.
• Statistical significance was not seen, despite power analysis that demonstrated a sufficient sample size to demonstrate a 35% difference in complete protection rates.
• Because the study sample was predominantly female, the ability to generalize is questionable.

No clear conclusions can be drawn from this study.