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

Zhejiang University

Status

Unknown

Conditions

Diffuse Large B-cell Lymphoma

Treatments

Other: placebo

Other: broken Ganoderma lucidum spore powder

Study type

Interventional

Funder types

Other

Identifiers

NCT04914143

2020-261

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;