Sanmukhani, J.J., Pawar, P., & Mittal, R. (2014). Ramosetron hydrochloride for the prevention of cancer chemotherapy induced nausea and vomiting: The Indian experience. South Asian Journal of Cancer, 3(2), 132–137. 

To evaluate the comparative efficacy and safety of ramosetron with ondansetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) with emetogenic therapy in adult patients in India

Enrolled patients were randomized into one of two groups receiving either ramosetron 0.1 mg (group 1) or ondansetron 4 mg (group 2). Tablets were taken in the morning beginning one hour before chemotherapy and continuing for five days. Medications that could influence CINV were not permitted during the trial. Rescue medications were used at the discretion of the investigator. Data were recorded for five days.

• N = 214  
• AGE RANGE = 18–75 years
• MALES: 73 (34%), FEMALES: 141 (65%)
• KEY DISEASE CHARACTERISTICS: Multiple cancers, emetogenic chemotherapy regimen
• OTHER KEY SAMPLE CHARACTERISTICS: Any patient who experienced vomiting 24 hours prior to study was excluded  

• SITE: Multi-site    
• SETTING TYPE: Outpatient  
• LOCATION: India

• PHASE OF CARE: Active antitumor treatment

Prospective, open-label, randomized, experimental design

• 4-point criteria adapted from National Cancer Institute Common Toxicity Criteria (NCICTC)
• Patient report of nausea and vomiting
• Investigator Global Assessment of Efficacy (IGAE) 4-point scale
• Adverse events recorded by investigators 

There was no significant difference in nausea and vomiting on day 1 between groups. After day 1, 64.0% of patients in group 1 achieved a complete response compared to 60.0% in group 2. More patients in group 1 as compared to group 2 achieved a complete response in the overall phase (27.2% [95% CI: 35.4%, 19.0%] versus 7.0% [95% CI: 12%, 2%]; difference 20.2% [95% CI: 29.7%, 10.2%]; P < 0.001) . Patients in group 1 reported less severe nausea than patients in group 2 on days 2 (p = 0.019), 3 (p = 0.020), 4 (p = 0.001), and 5 (p = 0.002). Patients in group 1 reported a less severe grade of vomiting on days 3 (p = 0.014) and 5 (p = 0.035).

Patients receiving ramosetron experienced less severe nausea and vomiting in delayed CINV compared to those receiving ondansetron.

• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: The majority of references used for this paper are old.

CINV continues to be a problematic side effect of chemotherapy. Nurses should frequently assess patients for nausea and vomiting in both the acute and delayed phase after administration of chemotherapy, taking note of the severity of both. The use of ramosetron for CINV in Indian patients is as effective as ondansetron and might be preferred for delayed CINV.