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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

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.

Conditions

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Breast Cancer Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

zhen qishen capsule and Oral Supplement of Yuyikang

Intervention Type DIETARY_SUPPLEMENT

chemotherapy

Intervention Type RADIATION

nutrition education

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo

Intervention Type DIETARY_SUPPLEMENT

chemotherapy

Intervention Type RADIATION

nutrition education

Intervention Type OTHER

Interventions

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zhen qishen capsule and Oral Supplement of Yuyikang

Intervention Type DIETARY_SUPPLEMENT

zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo

Intervention Type DIETARY_SUPPLEMENT

chemotherapy

Intervention Type RADIATION

nutrition education

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Peng Yuan

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Yuan, MD

Role: CONTACT

00861087788528

Facility Contacts

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Peng Yuan, MD

Role: primary

86-10-87788528

Other Identifiers

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CH-BC-036

Identifier Type: -

Identifier Source: org_study_id

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