Clinical trial NCT04912271: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chemotherapy-induced Nausea and Vomiting (CINV)
Keywords: delayed CINV
granisetron transdermal delivery system
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: complete response (CR) in delay phase of CINV
timeFrame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
Secondary outcomes:
measure: complete response (CR) in the acute and overall phase of CINV
timeFrame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
measure: complete control (CC) in delay phase of CINV
timeFrame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
measure: complete control (CC) in the acute and overall phase of CINV
timeFrame: From initiating administration of chemotherapy agents to day 1 (0-24 hours) and day 7 (0-168 hours)
measure: Patients' satisfaction with antiemetic therapy (assessed using a 10-cm visual analog scale at the time of patch removal
timeFrame: 7 days
Other outcomes:
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