Comparing transdermal granisetron to ondansetron for nausea in stem cell transplant patients
BMT-08: A Comparative Effectiveness Study of the Efficacy and Safety of Transdermal Granisetron to Ondansetron in the Prevention of Nausea and Vomiting in Patients Undergoing Preparative Chemotherapy and Hematopoietic Stem Cell Transplantation
This study is testing whether a skin patch with granisetron can help reduce nausea from chemotherapy better than the standard intravenous ondansetron in patients getting stem cell transplants.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04150614 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transdermal granisetron compared to intravenous ondansetron in reducing chemotherapy-induced nausea and vomiting (CINV) in patients undergoing hematopoietic stem cell transplants. It is an open-label, prospective trial that randomizes participants to receive either treatment alongside standard anti-emetic medications. Patients will self-administer the granisetron patch prior to chemotherapy, while those in the ondansetron group will receive the standard intravenous dosing. The study aims to assess the efficacy and safety of these interventions in managing CINV.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 receiving preparative chemotherapy for autologous or allogeneic stem cell transplants.
Not a fit: Patients with known hypersensitivity to granisetron or ondansetron, or those with a history of long QT syndrome, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and convenient option for managing nausea and vomiting in patients undergoing stem cell transplants.
How similar studies have performed: Other studies have shown varying success with similar anti-emetic approaches, but this specific comparison of transdermal granisetron and ondansetron is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years at time of enrollment receiving either a preparative regimen and either an autologous or allogeneic stem cell transplant. * No vomiting ≤ 24 hours prior to registration * No treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for ≤ 30 days' prior registration or planned during protocol therapy. No patients will be removed from these treatments for study enrollment purposes. * No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue antiemetic therapy). No patients will be removed from these treatments for study enrollment purposes. * No known hypersensitivity to granisetron Exclusion Criteria: * Concurrent use of amifostine * Known hypersensitivity to granisetron patch or ondansetron * Patients with a history of long QT syndrome or Torsade de Pointes
Where this trial is running
Chicago, Illinois
- University of Illinois Cancer Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Karen Sweiss, PharmD — University of Illinois at Chicago
- Study coordinator: Karen Sweiss, PharmD
- Email: ksweis2@uic.edu
- Phone: 312-996-0875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.