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

Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914143
• Other study ID #: 2020-261
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: xian li
• Phone: +8615158872648
• Email: lixian2018[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• broken Ganoderma lucidum spore powder
The experimental group was treated with broken Ganoderma lucidum spore powder after chemotherapy
• placebo
the control group was treated with placebo after chemotherapy

Locations

Country	Name	City	State
China	2ndAffiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of immunoglobulin (IGA, IgM, IgG)		half a year
Primary	T cell subsets	T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +)	half a year
Primary	Th1 / Th2 cytokines		half a year