Chemotherapy-induced Nausea and Vomiting (CINV)Phase 3NCT04912271
Granisetron Transdermal Patch for Prophylaxis of Delayed CINV
A Phase 3 study testing Granisetron transdermal patch, Palonosetron and Aprepitant in people with Chemotherapy-induced Nausea and Vomiting (CINV), run by Fudan University.
Trial summary
Transdermal granisetron has been shown to as effective as oral/ intravenous granisetron when administered with or without dexamethasone. However, it has not been evaluated specifically against the delayed response of chemotherapy-induced nausea and vomiting (CINV) in comparison with palonosetron, as the complete… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting (CINV)
- What is being tested?
- Granisetron transdermal patch, Palonosetron and Aprepitant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2021to 30 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged ≥ 18 years;
- Pathologically confirmed breast cancer;
- The physical status score ECOG ≤ 2;
- Life expectancy of ≥3 months;
- Patients first or had already received chemotherapy;
- Patients scheduled to receive HEC/MEC chemotherapy, and the main emetic drugs will be used within a single day;
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- Patients first use of granisetron transdermal patch;
- In accordance with the indication of chemotherapy and basic requirements;
- Peripheral haematology: Hb ≥8.0g/dL; absolute neutrophil count≥1.5×109/L; platelet count ≥80×109/L
- Blood biochemistry: Total bilirubin < 1.5×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST < 5×ULN, creatinine ≤ 1.5×ULN
- Patients voluntarily participate and sign the informed consent form;
- Be able to read, understand and complete patient diaries independently.
Who cannot join
- Contraindicated to 5-HT receptor antagonists, NK-1 receptor antagonist or dexamethasone;
- Patients have used 5-HT receptor antagonist, NK1 receptor antagonist or any study drugs within 4 weeks before chemotherapy
- Any nausea and vomiting (II or above) within 72 hours before the start of chemotherapy;
- According to the judgment of the investigators, there are concomitant diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the completion of the study;
- Patients scheduled to receive radiotherapy of whole body, brain or upper abdomen;
- Confirmed by craniocerebral CT or MRI, patients with brain tumor lesions or patients taking drugs to treat brain tumors or epileptic symptoms;
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- History of drug abuse and alcohol dependence;
- Pregnancy, lactation or intended pregnancy;
- History of allergic reactions to drugs with similar chemical structures, or to transdermal therapeutic systems, including commercial dressings such as Elastoplast®
- Unable to swallow, having intestinal obstruction, or other factors that affect the taking and absorption of the drug;
- Long-term use of any inhibitors or inducers of CYP3A4, or take these drugs within 4 weeks before the first day of chemotherapy;
- Other situations evaluated by investigators as unsuitable for enrollment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Granisetron Transdermal Delivery System Versus Palonosetron in the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting: a Phase 3 Non-inferiority Randomized Trial
Transdermal granisetron has been shown to as effective as oral/ intravenous granisetron when administered with or without dexamethasone. However, it has not been evaluated specifically against the delayed response of chemotherapy-induced nausea and vomiting (CINV) in comparison with palonosetron, as the complete response for the delayed phase was not reported in the comparative study by Seol et al (Support Care Cancer 2016;24:945-952). Thus, transdermal granisetron needs to be compared with palonosetron as part of dual and triple therapy in the delayed phase of CINV.
This investigator-initiated study aims to compare the efficacy of granisetron transdermal patch and palonosetron combined with NK-1 receptor antagonist and dexamethasone in the prevention of delayed CINV in Chinese breast cancer patients who received high emetic or moderate emetic chemotherapy.
- Being tested
- Granisetron transdermal patch, Palonosetron, Aprepitant, Fosaprepitant, Dexamethasone
- Keywords
- delayed CINV, granisetron transdermal delivery system
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron transdermal patchDrug
Also called sancuso
Granisetron transdermal delivery system (GTDS) is the first 5-HT3 drug to be transdermally delivered and represents a convenient alternative to oral and intravenous antiemetics for the treatment of chemotherapy-induced nausea and vomiting.
PalonosetronDrug
Palonosetron is a second-generation 5-HT3 receptor antagonist with proposed higher efficacy and sustained action for prophylaxis of postoperative nausea and vomiting (PONV).
AprepitantDrug
Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.
FosaprepitantDrug
Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.
DexamethasoneDrug
Dexamethasone, one of the glucocorticoids, has been suggested as a first-line drug for preventing low-level emetogenic chemotherapy- and radiotherapy-induced nausea and vomiting.
| Study group | Role | What they receive |
|---|---|---|
| Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone | Experimental | Patients received granisetron transdermal patch plus dexamethasone followed by oral aprepitant or fosaprepitant infusion Granisetron transdermal patch Aprepitant 125 mg PO D1, 80 mg PO D2-D3; Fosaprepitant 150 mg IV D1 Dexamethasone 7.5-10 mg IV/PO D1 Receives: Drug: Granisetron transdermal patch; Drug: Aprepitant; Drug: Fosaprepitant; Drug: Dexamethasone |
| Palonosetron, aprepitant or fosaprepitant, dexamethasone | Active comparator | Patients received intravenous palonosetron plus dexamethasone followed by oral aprepitant or fosaprepitant infusion Palonosetron 0.25 mg IV D1 Aprepitant 125 mg PO D1, 80 mg PO D2-D3; Fosaprepitant 150 mg IV D1 Dexamethasone 7.5-10 mg IV/PO D1 Receives: Drug: Palonosetron; Drug: Aprepitant; Drug: Fosaprepitant; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response (CR) in delay phase of CINV
To compare the complete response (CR) of Granisetron transdermal patch to Palonosetron (complete response is defined as no vomiting and no rescue medication) in delay phase of CINV
Measured: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Secondary outcomes (4)
complete response (CR) in the acute and overall phase of CINV
- To compare the complete response (CR) of Granisetron transdermal patch to Palonosetron (complete response is defined as no vomiting and no rescue medication) in the acute and overall phase of CINV
Measured: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
complete control (CC) in delay phase of CINV
- To compare the complete control (CC) of Granisetron transdermal patch to Palonosetron (complete control is defined as no vomiting, mild nausea and no rescue medication) in delay phase of CINV
Measured: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
complete control (CC) in the acute and overall phase of CINV
- To compare the complete control (CC) of Granisetron transdermal patch to Palonosetron (complete control is defined as no vomiting and no rescue medication) in the acute and overall phase of CINV
Measured: From initiating administration of chemotherapy agents to day 1 (0-24 hours) and day 7 (0-168 hours)
Patients' satisfaction with antiemetic therapy (assessed using a 10-cm visual analog scale at the time of patch removal
"dissatisfied" on the left end (0 cm) of visual analog scale and the "very satisfied" on the right end of visual analog scale (10 cm)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start10 Jun 2021 (estimated)
- Primary completion10 Jun 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and Vomiting (CINV)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912271
- Sponsor's protocol ID
- YBCSG-21-04
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Meng Y, Du Y, Mu Y, Li G, Li H, Guan X, Zhang J. Granisetron transdermal delivery system versus palonosetron in the prevention of long-delayed nausea and vomiting: a phase III randomized trial. Oncologist. 2026 Feb 5;31(3):oyag007. doi: 10.1093/oncolo/oyag007.
PubMed 41520166
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granisetron Transdermal Delivery System Versus Palonosetron in the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting: a Phase 3 Non-inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT04912271
- Acronym / sponsor ID
- YBCSG-21-04
- Keywords
- delayed CINV, granisetron transdermal delivery system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (estimated)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transdermal granisetron has been shown to as effective as oral/ intravenous granisetron when administered with or without dexamethasone. However, it has not been evaluated specifically against the delayed response of chemotherapy-induced nausea and vomiting (CINV) in comparison with palonosetron, as the complete response for the delayed phase was not reported in the comparative study by Seol et al (Support Care Cancer 2016;24:945-952). Thus, transdermal granisetron needs to be compared with palonosetron as part of dual and triple therapy in the delayed phase of CINV.
This investigator-initiated study aims to compare the efficacy of granisetron transdermal patch and palonosetron combined with NK-1 receptor antagonist and dexamethasone in the prevention of delayed CINV in Chinese breast cancer patients who received high emetic or moderate emetic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone | Experimental | Drug: Granisetron transdermal patch, Drug: Aprepitant, Drug: Fosaprepitant, Drug: DexamethasonePatients received granisetron transdermal patch plus dexamethasone followed by oral aprepitant or fosaprepitant infusion Granisetron transdermal patch Aprepitant 125 mg PO D1, 80 mg PO D2-D3; Fosaprepitant 150 mg IV D1 Dexamethasone 7.5-10 mg IV/PO D1 |
| Palonosetron, aprepitant or fosaprepitant, dexamethasone | Active comparator | Drug: Palonosetron, Drug: Aprepitant, Drug: Fosaprepitant, Drug: DexamethasonePatients received intravenous palonosetron plus dexamethasone followed by oral aprepitant or fosaprepitant infusion Palonosetron 0.25 mg IV D1 Aprepitant 125 mg PO D1, 80 mg PO D2-D3; Fosaprepitant 150 mg IV D1 Dexamethasone 7.5-10 mg IV/PO D1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female aged ≥ 18 years;
- Pathologically confirmed breast cancer;
- The physical status score ECOG ≤ 2;
- Life expectancy of ≥3 months;
- Patients first or had already received chemotherapy;
Key exclusion criteria (12 listed)
- Contraindicated to 5-HT receptor antagonists, NK-1 receptor antagonist or dexamethasone;
- Patients have used 5-HT receptor antagonist, NK1 receptor antagonist or any study drugs within 4 weeks before chemotherapy
- Any nausea and vomiting (II or above) within 72 hours before the start of chemotherapy;
- According to the judgment of the investigators, there are concomitant diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the completion of the study;
- Patients scheduled to receive radiotherapy of whole body, brain or upper abdomen;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granisetron transdermal patchAlso: sancusoGranisetron transdermal delivery system (GTDS) is the first 5-HT3 drug to be transdermally delivered and represents a convenient alternative to oral and intravenous antiemetics for the treatment of chemotherapy-induced nausea and vomiting. | Drug | Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone |
| PalonosetronPalonosetron is a second-generation 5-HT3 receptor antagonist with proposed higher efficacy and sustained action for prophylaxis of postoperative nausea and vomiting (PONV). | Drug | Palonosetron, aprepitant or fosaprepitant, dexamethasone |
| AprepitantAprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors. | Drug | Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone, Palonosetron, aprepitant or fosaprepitant, dexamethasone |
| FosaprepitantFosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting. | Drug | Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone, Palonosetron, aprepitant or fosaprepitant, dexamethasone |
| DexamethasoneDexamethasone, one of the glucocorticoids, has been suggested as a first-line drug for preventing low-level emetogenic chemotherapy- and radiotherapy-induced nausea and vomiting. | Drug | Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone, Palonosetron, aprepitant or fosaprepitant, dexamethasone |
Primary outcome
complete response (CR) in delay phase of CINV
Time frame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
To compare the complete response (CR) of Granisetron transdermal patch to Palonosetron (complete response is defined as no vomiting and no rescue medication) in delay phase of CINV
4 secondary outcomes
complete response (CR) in the acute and overall phase of CINV
Time frame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
complete control (CC) in delay phase of CINV
Time frame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
complete control (CC) in the acute and overall phase of CINV
Time frame: From initiating administration of chemotherapy agents to day 1 (0-24 hours) and day 7 (0-168 hours)
Patients' satisfaction with antiemetic therapy (assessed using a 10-cm visual analog scale at the time of patch removal
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 41520166Liu X, Meng Y, Du Y, Mu Y, Li G, Li H, Guan X, Zhang J. Granisetron transdermal delivery system versus palonosetron in the prevention of long-delayed nausea and vomiting: a phase III randomized trial. Oncologist. 2026 Feb 5;31(3):oyag007. doi: 10.1093/oncolo/oyag007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Granisetron transdermal patch, Palonosetron and Aprepitant in people with Chemotherapy-induced Nausea and Vomiting (CINV), run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, MD,PhD (+8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (CR) in delay phase of CINV (time frame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.