About this trial
To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, regardless of sex
Histologically or cytologically confirmed lung cancer
Expected survival ≥ 3 months
Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Low dose of Megestrol Acetate Oral Suspension combined with standard therapy
DrugA single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days.
Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy
DrugA single dose of 625 mg/day, administered once daily (QD) for 7 consecutive days.
High dose of Megestrol Acetate Oral Suspension combined with standard therapy
DrugA single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days.
Megestrol Acetate Oral Suspension Placebo combined with standard therapy
DrugA single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle
Proportion of Subjects Experiencing No Nausea During 0-120 Hours After Initiation of the First Chemotherapy Cycle
Secondary outcomes
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
Sponsors and contacts
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