To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients
This multicenter, randomized, double-blind, placebo-controlled parallel-group study evaluates the efficacy, safety, and pharmacokinetic profile of megestrol acetate oral suspension in preventing nausea and vomiting induced by highly emetogenic chemotherapy. The trial plans to enroll 132 chemotherapy-naive malignant solid tumor patients scheduled to undergo initial single-day highly emetogenic chemotherapy regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
A single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days.
A single dose of 625 mg/day, administered once daily (QD) for 7 consecutive days.
A single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle
Time frame: From 0 to 168 Hours After Initiation of Chemotherapy
Proportion of Subjects Experiencing No Nausea During 0-120 Hours After Initiation of the First Chemotherapy Cycle
Time frame: From 0 to 120 Hours After Initiation of Chemotherapy
Proportion of Subjects Achieving Complete Response (No significant nausea, No vomiting, etc. ) in the Acute, Delayed, Extended Delayed, 0-120 h, and 0-168 h Phases During the First Chemotherapy Cycle
Time frame: From 0 to 168 Hours After Initiation of Chemotherapy
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A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.