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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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
broken Ganoderma lucidum spore powder
placebo
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring broken Ganoderma lucidum spore powder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • 2ndAffiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

placebo comparator group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 1, 2021
Last Updated
June 3, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04914143
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
broken Ganoderma lucidum spore powder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
placebo comparator group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
broken Ganoderma lucidum spore powder
Intervention Description
The experimental group was treated with broken Ganoderma lucidum spore powder after chemotherapy
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
the control group was treated with placebo after chemotherapy
Primary Outcome Measure Information:
Title
Detection of immunoglobulin (IGA, IgM, IgG)
Time Frame
half a year
Title
T cell subsets
Description
T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +)
Time Frame
half a year
Title
Th1 / Th2 cytokines
Time Frame
half a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xian li
Phone
+8615158872648
Email
lixian2018@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
yun liang
Phone
+8613957136178
Email
liangyun@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yun liang
Organizational Affiliation
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yun liang
Phone
+8613957136178
Email
liangyun@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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