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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of Megestrol Acetate Oral Suspension | Experimental |
| |
| Medium dose of Megestrol Acetate Oral Suspension | Experimental |
| |
| High dose of Megestrol Acetate Oral Suspension | Experimental |
| |
| Megestrol Acetate Oral Suspension Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose of Megestrol Acetate Oral Suspension combined with standard therapy | Drug | A single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From 0 to 168 Hours After Initiation of Chemotherapy |
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Inclusion 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, PHD | Contact | +86 20-87343458 | zhangli@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, PHD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
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| Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy | Drug | 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 | Drug | 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 | Drug | A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days. |
|
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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