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

Not Applicable

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Other: broken Ganoderma lucidum spore powder; Other: placebo

• Registration Number: NCT04914143
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-06
• Status Verified: 2021-06
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	broken Ganoderma lucidum spore powder	-
placebo comparator group	placebo	-

Primary Outcome Measures

Name	Time	Method
Th1 / Th2 cytokines	half a year
Detection of immunoglobulin (IGA, IgM, IgG)	half a year
T cell subsets	half a year	T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +)

Trial Locations

Locations (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China