The Effect of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy
NCT ID: NCT02771756
Last Updated: 2016-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2015-05-31
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
zhen qishen capsule and Oral Supplement of Yuyikang
chemotherapy
nutrition education
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.
zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo
chemotherapy
nutrition education
Interventions
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zhen qishen capsule and Oral Supplement of Yuyikang
zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo
chemotherapy
nutrition education
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Peng Yuan
Chief Physician
Principal Investigators
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Peng Yuan, MD
Role: PRINCIPAL_INVESTIGATOR
Chief physician
Locations
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National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CH-BC-036
Identifier Type: -
Identifier Source: org_study_id
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