diffuse large B-cell lymphoma
Conditions
Interventions
Experimental Group:Xinlikang capsules were given orally after meals 5 capsules each time 3 times a day for 12 weeks
Control group:Mimetic capsules were taken orally after meals, 5 capsules each time, 3 times a day for 12 weeks
Sponsors
Sun Yat-sen University Cancer CenterWeifang Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 999 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria Participants must meet the following criteria to be eligible for this study: 1) Age =18 years old; 2) Newly diagnosed patients with diffuse large B-cell lymphoma according to the criteria of the Chinese Lymphoma Treatment Guidelines (2023 Edition); 3) According to the relevant guidelines the first-line treatment of chemotherapy + immunotherapy recommended by the Chinese lymphoma Treatment guidelines (2023 edition) has been completed and the course of treatment has been completed including RCHOP±ISRT Pola-R-CHP R-miniCHOP R-CDOP R-CEOP and other RCHOP-like chemotherapy protocols as well as subsequent consolidation treatment regimens (such as two cycles of CD20 monoclonal antibody use CNS prophylactic treatment with methotrexate or cytarabine etc.); 4) Metabolic complete remission as assessed by PET/CT during or after chemotherapy; 5) Completion of all chemotherapy treatment courses for more than one month; 6) BFI fatigue score =4 points; 7) Expected survival =6 months; 8) No treatment plans for CD20 monoclonal antibodies radiotherapy chemotherapy lenalidomide thymosin targeted drugs biological agents immunosuppressants other traditional Chinese medicine decoctions or Chinese patent medicines for at least 3 months in the future; 9) No plans for grade 3-4 surgeries for at least 3 months in the future; 10) Normal mental awareness able to correctly understand the content of the questionnaire and able to complete the questionnaire with assistance or independently; 11) Fertile women and men agree to take contraceptive measures during the treatment period and for one month after the treatment; 12) Voluntary participation in the clinical trial and signing of the informed consent form with the signing of the informed consent form in compliance with Good Clinical Practice requirements.
Exclusion criteria
Exclusion criteria: Exclusion criteria Potential participants who met the inclusion criteria were excluded if they met any of the following criteria: 1) participants with CNS involvement at initial diagnosis; 2) allergic or intolerant to Xinlikang capsule or its component drugs; 3) significant abnormal liver and renal function: ALT AST GGT=3 ULN; BUN Cr=3 ULN; 4) severe abnormal bone marrow function: white blood cell =1.0×10^9/L neutrophil =0.5×10^9/L platelet =30×10^9/L hemoglobin =6g/dL; 5) participants with viral infection (HIV infection or uncontrolled HBV HCV infection etc.) bacterial infection and other immune-related diseases judged by clinicians as having an impact on immune function; Hepatitis B Virus (HBV) DNA detection in participants with a history of chronic hepatitis B exceeds the lower limit of detection or 1000 copies /mL or 500 IU/mL (the higher is the reference); participants who are positive for Hepatitis C Virus (HCV) antibodies have HCV RNA tests that exceed the lower limit of detection of the assay or 1000 copies /mL or 500 IU/mL (whichever is higher is the reference). 6) participants with other tumors or hematological malignancies. 7) participate in another clinical trial 30 days before screening or during the trial; 8) participants who were deemed unsuitable to participate in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FACIT Fatigue Scale score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the absolute counts (cells /uL) and relative counts (%) of NK natural killer cells, CD3+ total T cells, CD4+ helper T cells, CD8+ cytotoxic T cells, and CD4+/CD8+ ratio from baseline in peripheral blood lymphocyte subtype analysis;Differences in mean FACIT Fatigue Scale score, BFI, FACT-Lym total score, five functional subscale scores, FACT-G, and TOI;Change in hematological parameters (WBC, RBC, Hb, PLT, neutrophils, total lymphocyte count, and monocyte count) from baseline;The difference in the proportion of FACIT Fatigue Scale score increase by 3 points, FACT-Lym total score increase by 6.5 points, TOI score increase by 5.5 points, and FACT-G score increase by 3 points from baseline;Change in BFI, FACT-Lym total score, five functional subscale scores, FACT-G, and TOI from baseline;Change in FACIT Fatigue Scale score from baseline;The difference in the proportion of CD4+ helper T cells (cells /uL) that increased by 30% or 100 cells /uL from baseline in peripheral blood lymphocyte subtype analysis; | — |
Countries
China
Contacts
Public ContactCai Qingqing
Sun Yat-sen University Cancer Center
Outcome results
None listed