Breast Cancer, Lung Cancer
Conditions
Keywords
Breast cancer, Lung cancer, Nutritional support, Safety, Effectiveness
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.
Interventions
OTHERnutrition education
DIETARY_SUPPLEMENTzhen qishen capsule and Oral Supplement of Yuyikang
DIETARY_SUPPLEMENTzhen qishen capsule placebo and Oral Supplement of Yuyikang placebo
RADIATIONchemotherapy
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Necrosis Factor α change status | 6 weeks and 9 weeks after baseline. |
| interleukin 6 change status | 6 weeks and 9 weeks after baseline. |
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| 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. |
| Aspartate Aminotransferase change status | 6 weeks and 9 weeks after baseline. |
| 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. |
Other
| 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 |
Countries
China
Contacts
Primary ContactPeng Yuan, MD
Outcome results
None listed