Transdermal Granisetron vs Ondansetron for Nausea and Vomiting
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Recruiting
Phase 4Interventional Study
Nausea With Vomiting Chemotherapy-Induced
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Supportive Care
Participants needed
90 (estimated)
Sponsor
University of Illinois at Chicago · Other
Who this trial is looking for
This trial is looking for patients aged 18-75 who are having a stem cell transplant and experiencing nausea and vomiting from chemotherapy. Participants will compare two treatments to see which one is more effective in reducing these symptoms.
Are You a Good Fit for This Trial?
Must not be takingAntipsychotic agents
You may be able to join if
I am between 18 and 75 years old.
I am receiving a stem cell transplant.
I have not vomited in the past 24 hours.
I have not taken antipsychotic medications in the past 30 days.
I do not have known allergies to granisetron.
You may not be able to join if
I am using amifostine.
I have an allergy to granisetron patches or ondansetron.
I have a history of long QT syndrome.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-dru…
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.
Trial Locations
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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, pheno…
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
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