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

Last updated: May 12, 2016
Sponsor: Chinese Academy of Medical Sciences
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Breast Cancer

Cancer

Lung Disease

Treatment

N/A

Clinical Study ID

NCT02771756
CH-BC-036
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, ALTis 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

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 asthe second primary tumor

  • For any other reason, the researchers were unable to complete the study

Study Design

Total Participants: 300
Study Start date:
May 01, 2015
Estimated Completion Date:
May 31, 2016

Study 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.

Connect with a study center

  • National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

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