Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Chemotherapy-induced Nausea and Vomiting (CINV)

Treatments: Drug: Granisetron transdermal patch; Drug: Dexamethasone; Drug: Palonosetron; Drug: Aprepitant; Drug: Fosaprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT04912271

YBCSG-21-04

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female aged ≥ 18 years;

2. Pathologically confirmed breast cancer;

3. The physical status score ECOG ≤ 2;

4. Life expectancy of ≥3 months;

5. Patients first or had already received chemotherapy;

6. Patients scheduled to receive HEC/MEC chemotherapy, and the main emetic drugs will be used within a single day;

7. Patients first use of granisetron transdermal patch;

8. 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

9. Patients voluntarily participate and sign the informed consent form;

10. Be able to read, understand and complete patient diaries independently.

Exclusion criteria

1. Contraindicated to 5-HT receptor antagonists, NK-1 receptor antagonist or dexamethasone;
2. Patients have used 5-HT receptor antagonist, NK1 receptor antagonist or any study drugs within 4 weeks before chemotherapy
3. Any nausea and vomiting (II or above) within 72 hours before the start of chemotherapy;
4. 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;
5. Patients scheduled to receive radiotherapy of whole body, brain or upper abdomen;
6. Confirmed by craniocerebral CT or MRI, patients with brain tumor lesions or patients taking drugs to treat brain tumors or epileptic symptoms;
7. History of drug abuse and alcohol dependence;
8. Pregnancy, lactation or intended pregnancy;
9. History of allergic reactions to drugs with similar chemical structures, or to transdermal therapeutic systems, including commercial dressings such as Elastoplast®
10. Unable to swallow, having intestinal obstruction, or other factors that affect the taking and absorption of the drug;
11. Long-term use of any inhibitors or inducers of CYP3A4, or take these drugs within 4 weeks before the first day of chemotherapy;
12. Other situations evaluated by investigators as unsuitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Granisetron transdermal patch (other name: sancuso), aprepitant or fosaprepitant, dexamethasone

Experimental group

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

Treatment:

Drug: Aprepitant

Drug: Dexamethasone

Drug: Fosaprepitant

Drug: Granisetron transdermal patch

Palonosetron, aprepitant or fosaprepitant, dexamethasone

Active Comparator group

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

Treatment:

Drug: Aprepitant

Drug: Palonosetron

Drug: Dexamethasone

Drug: Fosaprepitant