Clinical trial NCT02771756: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Keywords: Breast cancer
Lung cancer
Nutritional support
Safety
Effectiveness
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2016-05-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight change rate
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Siderophilin change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Interleukin 1 change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: interleukin 6 change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Tumor Necrosis Factor α change status
timeFrame: 6 weeks and 9 weeks after baseline.
Secondary outcomes:
measure: Change status of the Gripping Power
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Prealbumin Blood Examination change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Albumin change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Total Bilirubin change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Bilirubin Direct change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Indirect Bilirubin change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Alkaline Phosphatase change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Alanine Aminotransferase change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Aspartate Aminotransferase change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Serum Creatinine change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Urine Nitrogen change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Lymphocyte Number change status
timeFrame: 6 weeks and 9 weeks after baseline.
measure: Hemoglobin change status
timeFrame: 6 weeks and 9 weeks after baseline.
Other outcomes:
measure: Quality of life questionnaire(QOL-C30)
timeFrame: At baseline,6 weeks and 9 weeks after baseline.
measure: Scored Patient-Generated Subjective Global Assessment(PG-SGA)
timeFrame: At baseline
Locations:
city: Beijing
country: China
facility: National Cancer Institute, Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chief physician
name: Peng Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References: