Anti-Nausea Medications for Preventing Kidney Damage
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if anti-nausea medicines can prevent kidney damage in individuals treated with cisplatin, a common chemotherapy drug. Researchers seek to understand how these medications, along with individual genetic differences, influence cisplatin's effects on the kidneys. Participants will receive one of three anti-nausea drugs: Granisetron, Ondansetron (Zofran), or Palonosetron (Aloxi). This trial may be suitable for those undergoing cisplatin treatment who have not had kidney cancer or recent exposure to certain other treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering an opportunity to contribute to research that could lead to new treatment options.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it requires no changes in chronic medications within 2 weeks before starting. This suggests you should maintain your current medication regimen without changes.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In earlier studies, palonosetron has shown promise in reducing kidney damage caused by the chemotherapy drug cisplatin. One study found that patients who took palonosetron had a lower risk of kidney injury from cisplatin, suggesting it might help protect the kidneys.
Conversely, research suggests that ondansetron may increase the risk of kidney problems when used with cisplatin. Some animal studies showed that ondansetron might worsen kidney damage by affecting how the body handles cisplatin.
For granisetron, the evidence is less clear, but there is some concern. Studies have suggested that using drugs like granisetron could increase the risk of kidney damage with cisplatin.
Overall, palonosetron appears to be the safest option among these treatments based on current evidence. However, more research is needed to fully understand the risks and benefits of each medication.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments—granisetron, ondansetron, and palonosetron—because they could change the way we prevent kidney damage during chemotherapy with cisplatin. Unlike standard anti-nausea treatments, which primarily focus on reducing vomiting and queasiness, these drugs are being explored for their potential to minimize the toxic effects of cisplatin on the kidneys. Granisetron, ondansetron, and palonosetron are known for their ability to block serotonin receptors, which is a new angle in preventing kidney damage compared to current options. This innovative approach could lead to better outcomes for patients undergoing chemotherapy, making treatment both safer and more effective.
What evidence suggests that this trial's anti-nausea medications could be effective in preventing kidney damage?
This trial will compare the effects of different anti-nausea medications on kidney health in patients receiving cisplatin. Research has shown that palonosetron, one of the treatments in this trial, might protect kidneys from damage caused by cisplatin, a chemotherapy drug known for harming kidneys. Specifically, studies have found that palonosetron reduces cisplatin's harmful effects on the kidneys, possibly making it a safer option for those receiving this treatment. In contrast, ondansetron, another treatment option in this trial, increases the risk of kidney damage when used with cisplatin, as it causes more of the drug to accumulate in the kidneys. Granisetron, also being tested in this trial, controls nausea from chemotherapy, but evidence about its effects on kidney health is less clear. Overall, palonosetron seems to offer protective benefits, unlike ondansetron, which might increase kidney risk.23678
Who Is on the Research Team?
Edgar Jaimes, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Melanie Joy, PharmD, PhD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who are prescribed cisplatin for treatment and have healthy kidneys (eGFR > 60 ml/min^2) and liver. Participants should not be pregnant, breastfeeding, or have a history of heavy alcohol use. They must avoid grapefruit juice, alcohol, certain medications, and herbal supplements before the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cisplatin and are evaluated for kidney toxicity with antiemetic regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Granisetron
- Ondansetron
- Palonosetron
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator
Rutgers University
Collaborator