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 Sciences & Peking Union Medical College

Status: Unknown

Conditions: Breast Cancer; Lung Cancer

Treatments: Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo; Radiation: chemotherapy; Other: nutrition education; Dietary Supplement: zhen qishen capsule and Oral Supplement of Yuyikang

Study type: Interventional

Funder types: Other

Identifiers

NCT02771756

CH-BC-036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

test group

Experimental group

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.

Treatment:

Radiation: chemotherapy

Dietary Supplement: zhen qishen capsule and Oral Supplement of Yuyikang

Other: nutrition education

placebo group

Placebo Comparator group

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.

Treatment:

Radiation: chemotherapy

Dietary Supplement: zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo

Other: nutrition education