Clinical trial NCT04914143: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diffuse Large B-cell Lymphoma
Keywords: broken Ganoderma lucidum spore powder
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Detection of immunoglobulin (IGA, IgM, IgG)
timeFrame: half a year
measure: T cell subsets
timeFrame: half a year
measure: Th1 / Th2 cytokines
timeFrame: half a year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
name: yun liang
role: PRINCIPAL_INVESTIGATOR
References: