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

Not Applicable

• Conditions: Breast Cancer; Lung Cancer
• Interventions: 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

• Registration Number: NCT02771756
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-04-18
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted QC: 2016-05-12
• Last Update Submitted: 2016-05-12
• Study First Posted: 2016-05-13
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	nutrition education	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	nutrition education	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.
test group	zhen qishen capsule and Oral Supplement of Yuyikang	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 and Oral Supplement of Yuyikang placebo	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.
test group	chemotherapy	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	chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
interleukin 6 change status	6 weeks and 9 weeks after baseline.
Weight change rate	6 weeks and 9 weeks after baseline.
Tumor Necrosis Factor α change status	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.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin change status	6 weeks and 9 weeks after baseline.
Change status of the Gripping Power	6 weeks and 9 weeks after baseline.
Lymphocyte Number change status	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.

Trial Locations

Locations (1)

National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China