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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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 is a second-generation 5-HT3 receptor antagonist with proposed higher efficacy and sustained action for prophylaxis of postoperative nausea and vomiting (PONV).
Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.
Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.
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.
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
Time frame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
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
Time frame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
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
Time frame: From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)
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
Time frame: From initiating administration of chemotherapy agents to day 1 (0-24 hours) and day 7 (0-168 hours)
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)
Time frame: 7 days
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