Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

Chemotherapy-induced Nausea and Vomiting (CINV) Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04912271
• Other study ID #: YBCSG-21-04
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 10, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2021
• Source: Fudan University
• Contact: Jian Zhang, MD,PhD
• Phone: +8664175590
• Email: syner2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 30, 2023
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting (CINV)
• Nausea
• Vomiting

Intervention

Drug:
• 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.
• 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).
• Aprepitant
Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.
• Fosaprepitant
Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Secondary	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	From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Secondary	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	From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Secondary	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	From initiating administration of chemotherapy agents to day 1 (0-24 hours) and day 7 (0-168 hours)
Secondary	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)	7 days