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This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.
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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; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy. |
| 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 body weight of >5% from baseline | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiongwen Zhang | Contact | 18683716951 | qiongwen.zhang@scu.edu.cn | |
| Qi Rao | Contact | 13870440265 | raoqi6543@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 | Radiation | radiotherapy ± chemotherapy |
|