Granisetron Patch vs Ondansetron for Nausea and Vomiting

Overseen By Annette R Kinsella, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Illinois at Chicago

Must not be taking: Antipsychotics, Amifostine

Disqualifiers: Long QT syndrome, Torsade de Pointes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 7 days

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to alleviate nausea and vomiting from chemotherapy in stem cell transplant patients. One group will use a granisetron patch (a transdermal patch), while the other will take ondansetron pills; both groups will also receive dexamethasone. The goal is to determine which approach more effectively reduces these side effects. This trial is for individuals who haven't recently experienced vomiting and are not taking certain antipsychotic medications. As a Phase 4 trial, the treatments have FDA approval and proven effectiveness, and this research aims to understand how they benefit more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like antipsychotic agents (e.g., risperidone, quetiapine) if you have been using them within 30 days before the trial or plan to use them during the trial. However, you can continue using medications like prochlorperazine for nausea if needed.

What is the safety track record for these treatments?

Research has shown that the granisetron patch, worn on the skin, is generally easy to use without problems. Studies found it to be as safe as taking granisetron orally. Occasionally, the patch may not adhere well, potentially reducing its effectiveness. Overall, it appears safe to use, with no major side effects reported.

Ondansetron is a common medicine for treating nausea and vomiting and is generally considered safe. However, rare reports have linked it to birth defects if used during pregnancy. Although uncommon, these cases are important to consider.

Both treatments have a strong safety record. These findings can reassure prospective trial participants about their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer new ways to manage nausea and vomiting. The Granisetron Transdermal Patch stands out since it delivers medication through the skin, which can be more convenient and comfortable than traditional oral or intravenous options. This patch provides a steady release of granisetron, potentially leading to more consistent symptom control. Meanwhile, Ondansetron, given intravenously, is already a well-established treatment, but pairing it with dexamethasone could enhance its effectiveness. Both approaches aim to improve patient comfort and outcomes by exploring different delivery methods and combinations.

What evidence suggests that this trial's treatments could be effective for chemotherapy-induced nausea and vomiting?

This trial will compare the effectiveness of the granisetron patch with ondansetron for treating nausea and vomiting. Research has shown that the granisetron patch, which participants in one arm of this trial may receive, can control these symptoms in about 60-76% of patients and works as well as the pill form. Ondansetron, given to participants in another arm of this trial, has proven very effective, with over 80% of patients experiencing no vomiting within 24 hours. Both treatments have been proven to help with chemotherapy-induced nausea and vomiting, making them strong options for managing these side effects. ^{2 4 6 7 8}

Who Is on the Research Team?

Karen Sweiss, PharmD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 undergoing stem cell transplant and chemotherapy, who haven't vomited in the last 24 hours or taken certain antipsychotic drugs recently. It's not for those allergic to granisetron or ondansetron, with a history of specific heart rhythm problems, or using amifostine.

Inclusion Criteria

I am not on long-term antipsychotic drugs but may take them for nausea.

I haven't taken any antipsychotic medications like risperidone or quetiapine in the last 30 days.

I have not vomited in the last 24 hours.

Exclusion Criteria

Known hypersensitivity to granisetron patch or ondansetron

I have a history of long QT syndrome or Torsade de Pointes.

I am currently taking amifostine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparative Chemotherapy

Participants receive preparative chemotherapy in preparation for hematopoietic stem cell transplantation

1-2 weeks

Daily visits for chemotherapy administration

Treatment

Participants are randomized to receive either transdermal granisetron or intravenous ondansetron along with dexamethasone to prevent CINV

7 days

Daily monitoring for nausea and vomiting

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessment

7 days

Quality of life questionnaire administered at Day +7

What Are the Treatments Tested in This Trial?

Interventions

• Granisetron Transdermal Patch
• Intravenous Dexamethasone
• Ondansetron

Trial Overview The study compares two anti-nausea treatments in patients receiving stem cell transplants: a granisetron patch versus ondansetron. The goal is to see which one better prevents nausea and vomiting caused by chemotherapy.

How Is the Trial Designed?

Group I: Arm 1 Active Control 2 Interventions

ARM 1 -transdermal granisetron plus intravenous dexamethasone

Group II: ARM 2 Active Control 2 Interventions

ARM 2 -intravenous ondansetron plus intravenous dexamethasone

Granisetron Transdermal Patch is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Kytril for:

• Nausea/Vomiting - Chemotherapy Induced
• Nausea/Vomiting - Radiation Induced
• Nausea/Vomiting - Postoperative

Approved in European Union as Kytril for:

• Nausea and vomiting associated with chemotherapy and radiotherapy
• Prevention and treatment of post-operative nausea and vomiting

Approved in Canada as Kytril for:

• Prevention of nausea and vomiting associated with chemotherapy and radiotherapy
• Prevention of post-operative nausea and vomiting

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

The granisetron transdermal delivery system (GTDS) is as effective as daily oral granisetron for controlling chemotherapy-induced nausea and vomiting (CINV), with 60% of patients achieving complete control compared to 65% with oral granisetron, demonstrating non-inferiority.

Both the GTDS and oral granisetron were well tolerated, with constipation being the most common side effect, indicating that the transdermal patch is a convenient and effective alternative for patients undergoing multi-day chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Boccia, RV., Gordan, LN., Clark, G., et al.[2022]

Granisetron is a highly effective and well-tolerated 5-HT3-receptor antagonist for managing nausea and vomiting caused by chemotherapy, radiation, and surgery, supported by extensive clinical trial data.

Its favorable safety profile, minimal drug-drug interactions, and effectiveness in special populations, including children and elderly patients, make granisetron a preferred antiemetic choice, especially for those with complex medical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granisetron: an update on its clinical use in the management of nausea and vomiting. Aapro, M.[2022]

The granisetron transdermal system (GTS) was found to be not inferior to ondansetron in controlling chemotherapy-induced nausea and vomiting (CINV), with complete response rates of 86.84% for GTS and 90.36% for ondansetron, meeting the study's primary endpoint.

Patients using GTS reported significantly higher quality of life scores compared to those using ondansetron, indicating that GTS not only effectively controls CINV but also enhances patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the granisetron transdermal system for the control of nausea and vomiting induced by highly emetogenic chemotherapy: a multicenter, randomized, controlled trial. Sun, S., Ko, YH., Jin, JY., et al.[2023]

The granisetron transdermal system (GTS) demonstrated non-inferior efficacy compared to intravenous and oral granisetron in controlling chemotherapy-induced nausea and vomiting (CINV) in a study of 276 Korean patients, with a complete response rate of 75.0% for GTS versus 74.6% for the control group.

Both GTS and control treatments were well tolerated and safe, with no significant differences in patient satisfaction, indicating that GTS is a convenient alternative for managing CINV during moderately emetogenic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients. Kim, JE., Hong, YS., Lee, JL., et al.[2018]

In a study comparing granisetron delivered via a transdermal patch to oral ondansetron for treating nausea and vomiting in early pregnancy, none of the patients using granisetron required rescue antiemetics, while 2 out of 12 patients using ondansetron did.

This suggests that granisetron TDS may be more effective in managing nausea and vomiting of pregnancy (NVP) without the need for additional medication, but further prospective studies are necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observational Case Series Evaluation of the Granisetron Transdermal Patch System (Sancuso) for the Management of Nausea/Vomiting of Pregnancy. Le, TN., Adler, MT., Ouillette, H., et al.[2018]

Granisetron transdermal delivery system (GTDS) is an effective and well-tolerated alternative to oral and intravenous antiemetics for preventing chemotherapy-induced nausea and vomiting, showing similar efficacy to both intravenous and oral granisetron and palonosetron.

GTDS has demonstrated good cardiovascular safety, but caution is advised for patients at risk of QTc interval prolongation and arrhythmias, highlighting the need for careful monitoring in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chemotherapy-induced nausea and vomiting in patients receiving multiple-day highly or moderately emetogenic chemotherapy: role of transdermal granisetron. Coluzzi, F., Mattia, C.[2017]

In a comparison of transdermal versus oral granisetron for controlling chemotherapy-induced nausea and vomiting (CINV) in 1086 cancer patients, oral granisetron was found to be more effective, achieving complete control of CINV better than the transdermal form.

There were no significant differences in the risk of constipation or QTc prolongation between the two administration routes, indicating that both forms have a similar safety profile regarding these specific side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal versus oral granisetron in controlling chemotherapy-induced nausea and vomiting: a meta-analysis. Chua, AV., Hernandez, ARB., Real, IO.[2021]

In a study of 184 chemotherapy-naive patients receiving high-dose cisplatin, granisetron effectively controlled vomiting in 57% to 60% of patients at doses of 10, 20, or 40 micrograms/kg, with complete prevention of vomiting in 40% to 47% of patients.

The 10-micrograms/kg dose was found to be as effective as higher doses (20 and 40 micrograms/kg) in preventing nausea and vomiting, and granisetron was well tolerated, with headache being the most common side effect reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of granisetron, a selective 5-hydroxytryptamine-3 receptor antagonist, in the prevention of nausea and vomiting induced by high-dose cisplatin. Navari, RM., Kaplan, HG., Gralla, RJ., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5056574/

Granisetron Transdermal System for Treatment of ... In this open label prescription registry study, the GTS was effective in reducing nausea and/or vomiting in 76% (39/51) of gastroparesis patients with ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12616-9

Prolonged administration of the granisetron transdermal ... Our trial indicated that the granisetron transdermal patch has good tolerance and safety. No statistical difference was found in QTc ...

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2015.33.15_suppl.e20660

Efficacy of transdermal granisetron patch in controlling ... Efficacy of transdermal granisetron patch in controlling chemotherapy-induced nausea and vomiting in gastrointestinal cancer patients.

4. onf.ons.org onf.ons.org/sites/default/files/2025-04/cinv-adult-evaluation-table_transdermal-granisetron-2025_0.pdf

Chemotherapy-Induced Nausea and Vomiting—Adult ... In this study, GTS was noninferior to ondansetron for CR of CINV during HEC initiation. Interpretation of the results are limited because of the lack of more ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3166600/

Efficacy and tolerability of transdermal granisetron for the ... The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3733872/

Use and cardiovascular safety of transdermal and other ... Safety and tolerability of transdermal granisetron​​ Loss of adhesion results in reduced drug delivery and can result in inefficacy. Among 308 patients receiving ...

7. fda.gov fda.gov/files/drugs/published/20239S023-Granisetron-Clinical-PREA.pdf

20239S023 Granisetron Clinical PREA Kytril I.V. (Granisetron). Study Title: Intravenous granisetron (Kytril) in the prevention of post-operative nausea and vomiting (PONV) in ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05325190?tab=table

Granisetron Transdermal Patch System for Prevention of ... This study explored the efficacy and safety of granisetron transdermal patch in the prevention of delayed nausea and vomiting caused by capeox chemotherapy.