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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04914143

Collaborator

(none)

120

Enrollment

Location

Arms

42.8

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma	Other: broken Ganoderma lucidum spore powder Other: placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 6, 2020

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group	Other: broken Ganoderma lucidum spore powder The experimental group was treated with broken Ganoderma lucidum spore powder after chemotherapy
Placebo Comparator: placebo comparator group	Other: placebo the control group was treated with placebo after chemotherapy

Arm

Intervention/Treatment

Experimental: Experimental group

Other: broken Ganoderma lucidum spore powder

The experimental group was treated with broken Ganoderma lucidum spore powder after chemotherapy

Placebo Comparator: placebo comparator group

Other: placebo

the control group was treated with placebo after chemotherapy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2ndAffiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Principal Investigator: yun liang, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04914143

Other Study ID Numbers:

2020-261

First Posted:

Jun 4, 2021

Last Update Posted:

Jun 4, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

broken Ganoderma lucidum spore powder

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Jun 4, 2021