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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02771756
• Other study ID #: CH-BC-036
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2016
• Last updated: May 12, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, MD
• Phone: 00861087788528
• Email: Yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Dietary Supplement:
• zhen qishen capsule and Oral Supplement of Yuyikang

• zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo

Radiation:
• chemotherapy

Other:
• nutrition education

Locations

Country	Name	City	State
China	National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life questionnaire(QOL-C30)		At baseline,6 weeks and 9 weeks after baseline.	Yes
Other	Scored Patient-Generated Subjective Global Assessment(PG-SGA)		At baseline	Yes
Primary	Weight change rate		6 weeks and 9 weeks after baseline.	Yes
Primary	Siderophilin change status		6 weeks and 9 weeks after baseline.	Yes
Primary	Interleukin 1 change status		6 weeks and 9 weeks after baseline.	Yes
Primary	interleukin 6 change status		6 weeks and 9 weeks after baseline.	Yes
Primary	Tumor Necrosis Factor a change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Change status of the Gripping Power		6 weeks and 9 weeks after baseline.	Yes
Secondary	Prealbumin Blood Examination change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Albumin change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Total Bilirubin change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Bilirubin Direct change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Indirect Bilirubin change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Alkaline Phosphatase change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Alanine Aminotransferase change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Aspartate Aminotransferase change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Serum Creatinine change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Urine Nitrogen change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Lymphocyte Number change status		6 weeks and 9 weeks after baseline.	Yes
Secondary	Hemoglobin change status		6 weeks and 9 weeks after baseline.	Yes