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

NCT ID: NCT04914143

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-06

Study Completion Date

2023-12-30

Brief Summary

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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

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Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental group

Group Type EXPERIMENTAL

broken Ganoderma lucidum spore powder

Intervention Type OTHER

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

placebo comparator group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

the control group was treated with placebo after chemotherapy

Interventions

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broken Ganoderma lucidum spore powder

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

Intervention Type OTHER

placebo

the control group was treated with placebo after chemotherapy

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yun liang

Role: PRINCIPAL_INVESTIGATOR

2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Locations

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2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xian li

Role: CONTACT

+8615158872648

yun liang

Role: CONTACT

+8613957136178

Facility Contacts

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yun liang

Role: primary

+8613957136178

Other Identifiers

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2020-261

Identifier Type: -

Identifier Source: org_study_id

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