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

Primary Purpose

Breast Cancer, Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
zhen qishen capsule and Oral Supplement of Yuyikang
zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo
chemotherapy
nutrition education
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Lung cancer, Nutritional support, Safety, Effectiveness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

test group

placebo group

Arm Description

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 placebo (2 capsules, Bid) and Oral Supplement of Yuyikang placebo (50g,Bid), a total of 150 people, are used for 42 days continuously.

Outcomes

Primary Outcome Measures

Weight change rate
Siderophilin change status
Interleukin 1 change status
interleukin 6 change status
Tumor Necrosis Factor α change status

Secondary Outcome Measures

Change status of the Gripping Power
Prealbumin Blood Examination change status
Albumin change status
Total Bilirubin change status
Bilirubin Direct change status
Indirect Bilirubin change status
Alkaline Phosphatase change status
Alanine Aminotransferase change status
Aspartate Aminotransferase change status
Serum Creatinine change status
Urine Nitrogen change status
Lymphocyte Number change status
Hemoglobin change status

Full Information

First Posted
April 18, 2016
Last Updated
May 12, 2016
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02771756
Brief Title
The Effect of Zhen Qi Shen Capsule Combined With Yu Yi Kang on Breast Cancer and Lung Cancer Patients With Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer
Keywords
Breast cancer, Lung cancer, Nutritional support, Safety, Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
test group
Arm Type
Experimental
Arm Description
Zhen qishen capsule (2 capsules, Bid) and Oral Supplement of Yuyikang (50g, Bid), a total of 150 people, are used for 42 days continuously.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
zhen qishen capsule and Oral Supplement of Yuyikang
Intervention Type
Dietary Supplement
Intervention Name(s)
zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo
Intervention Type
Radiation
Intervention Name(s)
chemotherapy
Intervention Type
Other
Intervention Name(s)
nutrition education
Primary Outcome Measure Information:
Title
Weight change rate
Time Frame
6 weeks and 9 weeks after baseline.
Title
Siderophilin change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Interleukin 1 change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
interleukin 6 change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Tumor Necrosis Factor α change status
Time Frame
6 weeks and 9 weeks after baseline.
Secondary Outcome Measure Information:
Title
Change status of the Gripping Power
Time Frame
6 weeks and 9 weeks after baseline.
Title
Prealbumin Blood Examination change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Albumin change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Total Bilirubin change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Bilirubin Direct change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Indirect Bilirubin change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Alkaline Phosphatase change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Alanine Aminotransferase change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Aspartate Aminotransferase change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Serum Creatinine change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Urine Nitrogen change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Lymphocyte Number change status
Time Frame
6 weeks and 9 weeks after baseline.
Title
Hemoglobin change status
Time Frame
6 weeks and 9 weeks after baseline.
Other Pre-specified Outcome Measures:
Title
Quality of life questionnaire(QOL-C30)
Time Frame
At baseline,6 weeks and 9 weeks after baseline.
Title
Scored Patient-Generated Subjective Global Assessment(PG-SGA)
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan, MD
Phone
00861087788528
Email
Yuanpeng01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, MD
Organizational Affiliation
Chief physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan, MD
Phone
86-10-87788528
Email
Yuanpeng01@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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