Tsukuda, M., Ishitoya, J., Mikami, Y., Matsuda, H., Katori, H., Horiuchi, C., … Toth, G. (2009). Antiemetic effects of granisetron and dexamethasone combination therapy during cisplatin-containing chemotherapy for head and neck cancer: Dexamethasone dosage verification trial. International Journal of Clinical Oncology, 14, 337–343.

To determine the optimal dose of dexamethasone in combination with granisetron for chemotherapy-induced nausea and vomiting (CINV) control with cisplatin-containing chemotherapy

Patients were randomized to either receive 8 mg dexamethasone before chemotherapy and 24, 48, and 72 hours after chemotherapy during cycle 1, and 16 mg dexamethasone at the same time periods with cycle 2 of chemotherapy (8 mg antecedent group), or dosing of dexamethasone in the opposite sequence. All patients also received 3 mg granisetron with each dexamethasone administration. Physicians had discretion to provide addition treatment in cases of extreme nausea or vomiting. Symptoms were evaluated daily for 5 days.

• The study consisted of 36 participants.
• Age was not reported.
• The sample was 33% female and 77% male.
• All patients had head and neck cancers, with the most prevalent being hypopharyngeal.
• The majority of patients (83%) were chemotherapy naïve.

The study was conducted at a single site in Japan.

All patients were in active treatment.

This was a randomized crossover trial.

• The National Cancer Institute's (NCI) Common Terminology Criteria (CTC) version 2.0 for appetite loss was used.
• Nausea grade was defined in terms of number of vomiting episodes and ability to ingest liquids.
• Complete response was defined as no occurrence of nausea and zero instances of vomiting or retching.

Overall efficacy rates ranged from 47.2% on day 5 to 88.9% on day 1. No differences were found at any time point between groups.

No difference was found in antiemetic effect between 8 mg and 16 mg dexamethasone dosing.

• The sample size was small.
• The antiemetic regimen did not contain all recommended medications.
• Use of rescue medications was not discussed nor included in the definition of complete response.
• Whether the study team conducted nausea grading or it was based on patient reports was not clear.
• Nausea was defined in terms of vomiting rather than a symptom itself.

The study suggests that lower dosages of dexamethasone may be as effective as higher doses for CINV management. Further research in this area is needed. Lower dosing may help to reduce potential side effects of steroids.