Diffuse Large B-cell Lymphoma
Conditions
Keywords
broken Ganoderma lucidum spore powder
Brief summary
The purpose of this study was to explore the effect of broken Ganoderma lucidum spore powder on improving the quality of life and immune recovery of patients after chemotherapy. Objective To observe the adjuvant treatment with broken wall Ganoderma lucidum spore powder in patients with diffuse large B-cell lymphoma after standard chemotherapy according to NCCN guidelines. To evaluate and compare the immunoglobulin (IGA, IgM, IgG), T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +), Th1 / Th2 cytokine determination, quality of life score, leukocyte recovery rate, infection rate, infection rate To evaluate the effect of Ganoderma lucidum spore powder in improving the quality of life and immune function of patients after chemotherapy. At the same time, the liver and kidney function and adverse drug events were closely monitored during the study to explore the clinical safety of wall broken Ganoderma lucidum spore powder as adjuvant drug.
Interventions
OTHERbroken Ganoderma lucidum spore powder
The experimental group was treated with broken Ganoderma lucidum spore powder after chemotherapy
OTHERplacebo
the control group was treated with placebo after chemotherapy
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diffuse large B-cell lymphoma，NOS * all patients were diagnosed for the first time * between 18-75 years old, male and female * ECoG 0-3 ，the expected survival was more than 6 months * the pregnancy test of women of childbearing age was negative; Male and female patients should agree to take effective contraceptive measures during the treatment period and one year of follow-up; * sign the informed consent before the test screening
Exclusion criteria
* those who are known to be allergic to the study drug or its related components; Or allergic patients * uncontrolled psychosis * participating in other trials at the same time, and using experimental drugs that may affect the efficacy and safety evaluation * impairment of liver and kidney function * HIV antibody positive; * HBsAg positive hepatitis B carriers and confirmed hepatitis B and C patients; * pregnant or lactating women and patients who do not agree to take effective contraceptive measures; * the patient is unable to swallow the capsule or has a disease or condition that seriously affects the gastrointestinal function;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of immunoglobulin (IGA, IgM, IgG) | half a year | — |
| T cell subsets | half a year | T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +) |
| Th1 / Th2 cytokines | half a year | — |
Countries
China
Contacts
Primary Contactxian li
Backup Contactyun liang
Outcome results
None listed