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

Last updated: June 3, 2021
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Lymphoma, B-cell

Hematologic Cancer

Treatment

N/A

Clinical Study ID

NCT04914143
2020-261
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 patientsshould agree to take effective contraceptive measures during the treatment period andone year of follow-up;
  • sign the informed consent before the test screening

Exclusion

Exclusion Criteria:

  • those who are known to be allergic to the study drug or its related components; Orallergic patients
  • uncontrolled psychosis
  • participating in other trials at the same time, and using experimental drugs that mayaffect 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 effectivecontraceptive measures;
  • the patient is unable to swallow the capsule or has a disease or condition thatseriously affects the gastrointestinal function;

Study Design

Total Participants: 120
Study Start date:
June 06, 2020
Estimated Completion Date:
December 30, 2023

Connect with a study center

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

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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