Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

NCT ID: NCT04912271

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2023-12-30

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.

Conditions

Chemotherapy-induced Nausea and Vomiting (CINV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Granisetron transdermal patch

Intervention Type: DRUG

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.

Aprepitant

Intervention Type: DRUG

Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.

Fosaprepitant

Intervention Type: DRUG

Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.

Dexamethasone

Intervention Type: DRUG

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.

Palonosetron, aprepitant or fosaprepitant, dexamethasone

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

Group Type: ACTIVE_COMPARATOR

Palonosetron

Intervention Type: DRUG

Palonosetron is a second-generation 5-HT3 receptor antagonist with proposed higher efficacy and sustained action for prophylaxis of postoperative nausea and vomiting (PONV).

Aprepitant

Intervention Type: DRUG

Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.

Fosaprepitant

Intervention Type: DRUG

Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.

Dexamethasone

Intervention Type: DRUG

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.

Interventions

Granisetron transdermal patch

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

Palonosetron

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

Aprepitant

Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.

Intervention Type: DRUG

Fosaprepitant

Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.

Intervention Type: DRUG

Dexamethasone

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.

Intervention Type: DRUG

Other Intervention Names

sancuso

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jian Zhang, MD,PhD

Role: CONTACT

syner2000@163.com

+8664175590 ext. 85000

Other Identifiers

YBCSG-21-04

Identifier Type: -

Identifier Source: org_study_id