Recruiting

Transdermal Granisetron vs. Ondansetron

Sponsor:

University of Illinois at Chicago

Code:

NCT04150614

Conditions

Nausea With Vomiting Chemotherapy-Induced

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Granisetron Transdermal Patch

Intravenous Dexamethasone

Ondansetron

Study Details

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.

Conditions

Nausea With Vomiting Chemotherapy-Induced

Study ID

NCT04150614

Start date

May 14, 2020

Status verified date

Nov, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Arm 1

ARM 1 -transdermal granisetron plus intravenous dexamethasone

active comparator: ARM 2

ARM 2 -intravenous ondansetron plus intravenous dexamethasone

Interventions

Granisetron Transdermal Patch

Antiemetic

Intravenous Dexamethasone

Antiemetic

Ondansetron

ondansetron

Primary outcome measure

  • To compare between the two study arms the number of patients achieving complete response (no vomiting and no use of rescue medications) during the acute period (0-24 hours post-chemotherapy) for patients receiving preparative chemotherapy and HSCT. [ Time Frame: 0 hours to 24 hours post-chemotherapy ]

Central Contacts and Locations

Central contacts

Karen Sweiss, PharmD

312-996-0875ksweis2@uic.edu

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Karen Sweiss, PharmD

312-996-0875ksweis2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • Hematopoietic Stem Cell Transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-11-12.