the Effect of Broken Ganoderma Lucidum Spore Powder on Quality of Life and Immune Function in Patients With Diffuse Large B-cell Lymphoma After Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Single Center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Broken Ganoderma Lucidum Spore Powder on Quality of Life and Immune Function in Patients With Diffuse Large B-cell Lymphoma After Chemotherapy

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Other: broken Ganoderma lucidum spore powder
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Other: broken Ganoderma lucidum spore powder<br>* The experimental group was treated with broken Ganoderma lucidum spore powder after chemotherapy<br>|
| Placebo Comparator: placebo comparator group<br> | Other: placebo<br>* the control group was treated with placebo after chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of immunoglobulin (IGA, IgM, IgG) |  | half a year | 
| T cell subsets | T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +) | half a year | 
| Th1 / Th2 cytokines |  | half a year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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broken Ganoderma lucidum spore powder