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The purpose of this study is to research more reasonable and safe methods of nutritional support to improve the nutritional status of tumor patients, which guarantees the anti-tumor treatment such as chemotherapy.
This study is a prospective, randomized, controlled clinical trials. 300 patients were randomly divided into 2 groups for its own control study.
Test group: Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g,Bid), a total of 150 people, are used for 42 days continuously.
Placebo group: Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g, Bid), a total of 150 people, are used for 42 days continuously.
The subjects were randomized to AB or BA parallely, and the two groups were given chemotherapy and nutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g, Bid), a total of 150 people, are used for 42 days continuously. |
|
| placebo group | Placebo Comparator | Zhen qishen capsule placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g,Bid), a total of 150 people, are used for 42 days continuously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zhen qishen capsule and Oral Supplement of Yuyikang | Dietary Supplement |
| ||
| zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change rate | 6 weeks and 9 weeks after baseline. | |
| Siderophilin change status | 6 weeks and 9 weeks after baseline. | |
| Interleukin 1 change status | 6 weeks and 9 weeks after baseline. | |
| interleukin 6 change status | 6 weeks and 9 weeks after baseline. | |
| Tumor Necrosis Factor α change status | 6 weeks and 9 weeks after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change status of the Gripping Power | 6 weeks and 9 weeks after baseline. | |
| Prealbumin Blood Examination change status | 6 weeks and 9 weeks after baseline. | |
| Albumin change status |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire(QOL-C30) | At baseline,6 weeks and 9 weeks after baseline. | |
| Scored Patient-Generated Subjective Global Assessment(PG-SGA) | At baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Yuan, MD | Contact | 00861087788528 | Yuanpeng01@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Yuan, MD | Chief physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Dietary Supplement |
|
| chemotherapy | Radiation |
|
| nutrition education | Other |
|
| 6 weeks and 9 weeks after baseline. |
| Total Bilirubin change status | 6 weeks and 9 weeks after baseline. |
| Bilirubin Direct change status | 6 weeks and 9 weeks after baseline. |
| Indirect Bilirubin change status | 6 weeks and 9 weeks after baseline. |
| Alkaline Phosphatase change status | 6 weeks and 9 weeks after baseline. |
| Alanine Aminotransferase change status | 6 weeks and 9 weeks after baseline. |
| Aspartate Aminotransferase change status | 6 weeks and 9 weeks after baseline. |
| Serum Creatinine change status | 6 weeks and 9 weeks after baseline. |
| Urine Nitrogen change status | 6 weeks and 9 weeks after baseline. |
| Lymphocyte Number change status | 6 weeks and 9 weeks after baseline. |
| Hemoglobin change status | 6 weeks and 9 weeks after baseline. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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