This prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Eligible subjects were screened and assigned to Arm 1 or Arm 2 according to medical protocol. Arm 1: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine; Arm 2: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone. Study drug administration commenced within 48 hours post-randomization, with follow-up visits and examinations completed as per protocol.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
On the first day of chemotherapy, a 60-minute intravenous infusion is administered prior to treatment
On the first day of chemotherapy, take 12mg orally. From the second day of chemotherapy until 3 days after chemotherapy concludes, take 3.75mg orally twice daily
From the first day of chemotherapy until three days after its completion, take 5mg orally each night before bedtime
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPercentage of patients achieving Complete Control of CINV from the first administration until 24 hours after the last administration of chemotherapy
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) from the first administration until 24 hours after the last administration of chemotherapy
Time frame: from the first administration until 24 hours after the last administration of chemotherapy
Percentage of patients achieving Complete Control of CINV during the acute phase, delayed phase, and super-delayed phase
To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) during the specified period.
Time frame: acute phase: from first chemotherapy administration until last administration; delayed phase: until 120 hours after last administration; super-delayed phase: from 120 hours to 168 hours after last administration
No significant nausea
To compare the proportion of subjects with no significant nausea (defined as maximum nausea on a visual analogue scale \<25 mm) during the specified period.
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No nausea
To compare the proportion of subjects with no nausea (defined as maximum nausea on a visual analogue scale \<5 mm) during the specified period.
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No emetic
To compare the proportion of subjects with no emetic event during the specified period
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
No rescue medication
To compare the proportion of subjects who received no rescue medication during the specified period.
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
Complete protection
To compare the proportion of subjects with complete protection (defined as patients who experienced no emetic event and received no rescue medication and had no significant nausea) during the specified period).
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
Total control
To compare the proportion of subjects with total control (defined as patients who experienced no emetic events and received no rescue medication and had no nausea) during the specified period.
Time frame: from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration
The score using the functional living index-emesis (FLIE) questionnaire
To compare the change of score using FLIE questionnaire before and after treatment.
Time frame: from first chemotherapy administration to 168 hours after last administration
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