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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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This study is a prospective, randomized, parallel-controlled clinical trial, aiming to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) in both the pre-cachexia and cachexia phases. Participants enrolled in the study are those with ES-SCLC in the pre-cachexia or cachexia phase who have not received systemic treatment and are not eligible for curative therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy | Experimental |
| |
| Standard Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension | Drug | Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with improved appetite based on A/CS-12 assessment | Week 3 | |
| The proportion of subjects with a relative increase in BMI from baseline | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Li | Contact | 18980601778 | windflower1991@vip.163.com | |
| Dan Pu | Contact | 13348826654 | danpu_87@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China School of Medicine/West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
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| standard treatment | Drug | standard treatment |
|
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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