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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Granisetron Transdermal Patch for nausea and vomiting?

Research shows that the Granisetron Transdermal Patch is as effective as oral granisetron in controlling nausea and vomiting caused by chemotherapy. It has been found to work well for both moderately and highly emetogenic (causing nausea and vomiting) chemotherapy, making it a reliable option for patients undergoing cancer treatment. ^{1 2 3 4 5}

Is the Granisetron Patch safe for humans?

The Granisetron Patch is generally safe and well-tolerated in humans, with good cardiovascular safety. However, caution is advised for people at risk of heart rhythm issues, as it may cause QTc interval prolongation (a heart rhythm problem). ^{1 3 4 5 6}

What makes the granisetron transdermal patch unique compared to other drugs for nausea and vomiting?

The granisetron transdermal patch is unique because it delivers the drug continuously over 7 days through the skin, offering a convenient alternative to oral or intravenous options for managing nausea and vomiting, especially in patients undergoing chemotherapy. ^{4 5 6 7 8}

Research Team

Karen Sweiss, PharmD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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 between 18 and 75 years old and will receive a stem cell transplant.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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]

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 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]

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]

References

1. United States 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. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

Transdermal versus oral granisetron in controlling chemotherapy-induced nausea and vomiting: a meta-analysis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Germany 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. [2018]

5. Korea (South) 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. [2023]

6. England 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. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Observational Case Series Evaluation of the Granisetron Transdermal Patch System (Sancuso) for the Management of Nausea/Vomiting of Pregnancy. [2018]

8. Germany 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. [2022]