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This study investigates nutritional status and outcomes of immuntherapy in cancer patients.
Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| megestrol acetate-olanzapine | Experimental | Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday |
|
| control | Placebo Comparator | Starch powder 50 mg, oral, everyday, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Megestrol Acetate and olanzapine | Drug | megestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | overall response rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | profression-free survival | 12 months |
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Inclusion Criteria:
For all oral medications patients must be able to comfortably swallow capsules;
Exclusion Criteria:
Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keke Nie, MD | Contact | 53268665078 | niekeke@uor.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| chunling zhang, MD | Qingdao Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao Central Hospital | Recruiting | Qingdao | Shandong | 266042 | China |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009369 | Neoplasms |
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday during the immunotherapy course or intolerable.
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| Starch powder 50 mg | Drug | Starch powder 50 mg, oral, everyday |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |