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

May 12, 2016 updated by: Peng Yuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Dietary supplement: zhen qishen capsule and Oral Supplement of Yuyikang
Radiation: chemotherapy
Other: nutrition education
PLACEBO_COMPARATOR: 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.
Radiation: chemotherapy
Other: nutrition education
Dietary supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight change rate
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Siderophilin change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Interleukin 1 change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
interleukin 6 change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Tumor Necrosis Factor α change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change status of the Gripping Power
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Prealbumin Blood Examination change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Albumin change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Total Bilirubin change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Bilirubin Direct change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Indirect Bilirubin change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Alkaline Phosphatase change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Alanine Aminotransferase change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Aspartate Aminotransferase change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Serum Creatinine change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Urine Nitrogen change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Lymphocyte Number change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.
Hemoglobin change status
Time Frame: 6 weeks and 9 weeks after baseline.
6 weeks and 9 weeks after baseline.

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life questionnaire(QOL-C30)
Time Frame: At baseline,6 weeks and 9 weeks after baseline.
At baseline,6 weeks and 9 weeks after baseline.
Scored Patient-Generated Subjective Global Assessment(PG-SGA)
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Peng Yuan, MD, Chief Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-BC-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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