The Effect of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized, Self Controlled Study on the Effect of Oral Supplement of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy

Conditions
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Breast Cancer, Lung Cancer

Intervention / Treatment
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* Dietary Supplement: zhen qishen capsule and Oral Supplement of Yuyikang
* Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo
* Radiation: chemotherapy
* Other: nutrition education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 18 and 70 years old Breast or lung cancer was diagnosed by pathology or cytology ECOG score: 0-2 points PG-SGA: 2-8 points, while the weight loss within 3 months less than 5% The organ function is good, with chemotherapy index. ANC is equal to or over 1.5 * 10^9/L, PLT is equal to or over 100* 10^9/L, HGB is equal to or over 90g/L Bilirubin is equal to or less than 1.5 times of the normal upper limit, AP, AST, ALT is less than or equal to 2 times of normal upper limit Ccr is equal to or over 50mL/min Life expectancy is equal to or over 12 weeks Exclusion Criteria: Complete or incomplete intestinal obstruction A severe infection or difficult to control diabetes History of organ transplantation, or current use of immunosuppressive agents An intervention in nutritional supplements, or a metabolic disorder Parenteral nutrition must be applied Alcoholism or drug addiction Pregnancy or lactation, or women of childbearing age refuse contraception There are potential factors that interfere with the mental, psychological, family, social or geographical and other factors of the research project There are other diseases that may interfere with the results of this study, such as the second primary tumor For any other reason, the researchers were unable to complete the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g, Bid), a total of 150 people, are used for 42 days continuously. | Dietary Supplement: zhen qishen capsule and Oral Supplement of Yuyikang<br> <br> Radiation: chemotherapy<br> <br> Other: nutrition education<br> <br> |
| Placebo Comparator: placebo group<br>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. | Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo<br> <br> Radiation: chemotherapy<br> <br> Other: nutrition education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Lung cancer, Nutritional support, Safety, Effectiveness