Low dose of Megestrol Acetate Oral Suspension combined with standard therapyMedium dose of Megestrol Acetate Oral Suspension combined with standard therapyHigh dose of Megestrol Acetate Oral Suspension combined with standard therapyMegestrol Acetate Oral Suspension Placebo combined with standard therapy
Low dose of Megestrol Acetate Oral Suspension combined with standard therapy: A 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: A 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: A single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days.
Megestrol Acetate Oral Suspension Placebo combined with standard therapy: A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years, regardless of sex
2. Histologically or cytologically confirmed lung cancer
3. Expected survival ≥ 3 months
4. Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating
5. Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements/restrictions Exclusion Criteria
1\. Received or scheduled to receive concurrent radiotherapy within 7 days prior to enrollment through Day 1-8 of treatment 2. Systemic corticosteroid therapy or sedating antihistamines within 7 days prior to enrollment 3. Poorly controlled serous cavity effusions (pleural/peritoneal/pericardial) 4. Severe cardiovascular diseases within 3 months prior to enrollment 5. Participation in other clinical trials within 30 days prior to enrollment
Primary outcome measure(s)
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle — 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 — From 0 to 120 Hours After Initiation of Chemotherapy
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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