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

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: Breast Cancer; Lung Cancer
• Intervention / Treatment: Dietary supplement: zhen qishen capsule and Oral Supplement of Yuyikang; Radiation: chemotherapy; Other: nutrition education; Dietary supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo

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

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Peng Yuan, MD; Phone Number: 86-10-87788528; Email: Yuanpeng01@hotmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	6 weeks and 9 weeks after baseline.
Siderophilin change status	6 weeks and 9 weeks after baseline.
Interleukin 1 change status	6 weeks and 9 weeks after baseline.
interleukin 6 change status	6 weeks and 9 weeks after baseline.
Tumor Necrosis Factor α change status	6 weeks and 9 weeks after baseline.

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Peng Yuan, MD, Chief Physician

Study record dates

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: Safety; Breast cancer; Lung cancer; Effectiveness; Nutritional support
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Breast Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CH-BC-036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES