NCT04150614 BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
| NCT ID | NCT04150614 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Illinois at Chicago |
| Condition | Nausea With Vomiting Chemotherapy-Induced |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2020-05-14 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2020-05-14 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients undergoing either an autologous or allogeneic hematopoietic stem cell transplant (HSCT) and receiving preparative chemotherapy experience a considerable amount of chemotherapy-induced nausea and vomiting (CINV). Current strategies at reducing CINV in this patient population are suboptimal due to lack of efficacy and supportive evidence, potential for increased adverse events, and drug-drug and drug-disease contraindications.
Eligibility 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
Contact & Investigator
Karen Sweiss, PharmD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT04150614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Nausea With Vomiting Chemotherapy-Induced. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04150614 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04150614 currently recruiting?
Yes, NCT04150614 is actively recruiting participants. Contact the research team at ksweis2@uic.edu for enrollment information.
Where is the NCT04150614 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04150614 clinical trial?
NCT04150614 is sponsored by University of Illinois at Chicago. The principal investigator is Karen Sweiss, PharmD at University of Illinois at Chicago. The trial plans to enroll 90 participants.