Back to resultsGranisetron Transdermal Patch for Prophylaxis of Delayed CINV
Primary Purpose
Chemotherapy-induced Nausea and Vomiting (CINV)
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Granisetron transdermal patch
Palonosetron
Aprepitant
Fosaprepitant
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting (CINV) focused on measuring delayed CINV, granisetron transdermal delivery system
Eligibility Criteria
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone
Palonosetron, aprepitant or fosaprepitant, dexamethasone
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
complete response (CR) in the acute and overall phase of CINV
1. 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
complete control (CC) in delay phase of CINV
2. 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
complete control (CC) in the acute and overall phase of CINV
3. 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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04912271
Brief Title
Granisetron Transdermal Patch for Prophylaxis of Delayed CINV
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 10, 2021 (Anticipated)
Primary Completion Date
June 10, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting (CINV)
Keywords
delayed CINV, granisetron transdermal delivery system
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone
Arm Type
Experimental
Arm Description
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
Arm Title
Palonosetron, aprepitant or fosaprepitant, dexamethasone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Granisetron transdermal patch
Other Intervention Name(s)
sancuso
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Intervention Description
Palonosetron is a second-generation 5-HT3 receptor antagonist with proposed higher efficacy and sustained action for prophylaxis of postoperative nausea and vomiting (PONV).
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Intervention Description
Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant
Intervention Description
Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
complete response (CR) in delay phase of CINV
Description
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
Time Frame
From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Secondary Outcome Measure Information:
Title
complete response (CR) in the acute and overall phase of CINV
Description
1. 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
Time Frame
From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Title
complete control (CC) in delay phase of CINV
Description
2. 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
Time Frame
From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Title
complete control (CC) in the acute and overall phase of CINV
Description
3. 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
Time Frame
From initiating administration of chemotherapy agents to day 1 (0-24 hours) and day 7 (0-168 hours)
Title
Patients' satisfaction with antiemetic therapy (assessed using a 10-cm visual analog scale at the time of patch removal
Description
"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)
Time Frame
7 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhang, MD,PhD
Phone
+8664175590
Ext
85000
Email
syner2000@163.com
12. IPD Sharing Statement
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Granisetron Transdermal Patch for Prophylaxis of Delayed CINV
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