Berrak, S.G., Ozdemir, N., Bakirci, N., Turkkan, E., Canpolat, C., Beker, B., & Yoruk, A. (2007). A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy. Supportive Care in Cancer, 15, 1163–1168. 

To compare tolerance for and the efficacy of granisetron at 10 µg/kg versus 40 µg/kg for the prevention of acute and delayed nausea and vomiting in patients receiving moderately emetogenic chemotherapy

Each patient was randomly assigned to receive either 10 µg/kg or 40 µg/kg of granisetron during alternating cycles of chemotherapy. Medication was given intravenously 30 minutes prior to the start of chemotherapy, and patients received no other prophylactic antiemetic medication. The dose was blinded from treating doctors, nurses, and patients. Data were collected the first five days following chemotherapy.

• N = 18
• MEAN AGE = 7.7 years (range = 1–23 years)
• MALES: 13 (72%), FEMALES: 5 (28%)
• KEY DISEASE CHARACTERISTICS: All had optic pathway tumors
• OTHER KEY SAMPLE CHARACTERISTICS: Scheduled to receive either carboplatin alone or carboplatin with vincristine

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Marmara University Medical Center in Istanbul, Turkey

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

Randomized, double-blinded crossover trial

• Nausea and emesis were recorded by patients and parents on self-reported diary cards that were scored as a 1 (complete response [absence of nausea or vomiting]), 2 (major response [one emesis episode or moderate nausea]), 3 (minor response [two to four emesis episodes independent of nausea]), or 4 for (treatment failure [more than four emesis episodes per day]).
• A safety assessment included any report of an adverse event by patients or parents and vital signs recorded by the physician.

Antiemetic efficacy scores were not different between the two doses (1.045 for the 40 µg/kg dose and 1.040 for the 10 µg/kg dose [p = 0.330]). Neither gender nor age affected antiemetic efficacy scores. No granisetron-related side effects were reported. No patients withdrew from the study.

Granisetron was an effective antiemetic medication for moderately emetogenic chemotherapy with the majority of patients experiencing a complete antiemetic response over five days postchemotherapy. Higher doses of granisetron were associated with no significant improvements in efficacy. Granisetron was safe with no adverse events associated with administration.

• Small sample (< 30)
• Measurement/methods not well described

Granisetron was a safe and effective medication that prevented acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy.