NCT04914143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

2.6 years

First QC Date

June 1, 2021

Last Update Submit

June 3, 2021

Conditions

Diffuse Large B-cell Lymphoma

Keywords

broken Ganoderma lucidum spore powder

Outcome Measures

Primary Outcomes (3)

  • Detection of immunoglobulin (IGA, IgM, IgG)

    half a year

  • T cell subsets

    T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +)

    half a year

  • Th1 / Th2 cytokines

    half a year

Study Arms (2)

Experimental group

EXPERIMENTAL
Other: broken Ganoderma lucidum spore powder

placebo comparator group

PLACEBO COMPARATOR
Other: placebo

Interventions

broken Ganoderma lucidum spore powderOTHER

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

Experimental group
placeboOTHER

the control group was treated with placebo after chemotherapy

placebo comparator group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • yun liang

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xian li

CONTACT

+8615158872648lixian2018@zju.edu.cn

yun liang

CONTACT

+8613957136178liangyun@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 4, 2021

Study Start

June 6, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)