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

Chinese Academy of Medical Sciences300 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Breast Cancer Lung Cancer

Interventions

zhen qishen capsule and Oral Supplement of YuyikangDIETARY_SUPPLEMENT

zhen qishen capsule placebo and Oral Supplement of Yuyikang placeboDIETARY_SUPPLEMENT

chemotherapyRADIATION

nutrition education

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING