Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Brief summary
To evaluate the efficacy and safety of Xinlikang capsule in the treatment of cancer-related fatigue (CRF) and peripheral blood lymphocytes in patients with diffuse large B-cell lymphoma (DLBCL) who achieved complete remission (CR) after all courses of chemotherapy-containing regimens
Interventions
DRUGXinlikang capsules
Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks
DRUGmimic capsules
mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old; 2. Newly diagnosed diffuse large B lymphoma (DLBCL); 3. Patients had completed the first-line treatment of chemotherapy and immunotherapy and the course of treatment had been completed. 4. Metabolic complete response (CR) was evaluated by PET/CT during or after chemotherapy. 5. Had completed the full course of chemotherapy-containing regimen for more than 30-90 days; 6. BFI fatigue score ≥4; 7. The expected survival time was ≥6 months; 8. No treatment plan for CD20 monoclonal antibody, radiotherapy, chemotherapy, lenalidomide, thymopeptides, targeted drugs, biological agents, immunosuppressive agents, other Chinese medicine decoction or Chinese patent medicine in the next 3 months; 9. No grade 3-4 surgery plan is expected in the next 3 months; 10. They had normal mental consciousness, could understand the content of the questionnaire correctly, and could complete the questionnaire with assistance or independently; 11. Women and men of childbearing age agreed to use contraception during and for 1 month after treatment; 12. They volunteered to participate in the clinical trial and signed the informed consent form, which was in accordance with the requirements of Good Clinical Practice (GCP).
Exclusion criteria
1. DLBCL subjects with CNS involvement at initial diagnosis; 2. Allergic or intolerant to Xinlikang capsule or its component drugs; 3. Significant abnormal liver and kidney function: ALT, AST, GGT≥3 ULN; BUN and 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. Patients with HIV virus infection, bacterial infection and other immune-related diseases that affect immune function as judged by clinicians; 6. Uncontrolled HBV or HCV infection: Hepatitis B Virus (HBV) DNA testing exceeding the lower limit of detection or 1000 copies /mL or 500 IU/mL (the higher is the reference) during screening in patients with a history of chronic hepatitis B; HCV RNA detection in patients with a history of Hepatitis C Virus (HCV) infection during the screening period exceeded the detection limit of the assay or 1000 copies /mL or 500 IU/mL (whichever was higher was used as a reference). 7. Patients with other malignancies. 8. Enrollment in another clinical trial 30 days before screening or during the trial; 9. Persons who were deemed by the investigator to be ineligible to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of FACIT Fatigue Scale score | From baseline to 12 weeks of treatment | The scale ranges from 0 to 4, with lower scores indicating better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference of FACIT Fatigue Scale scores | Differences in FACIT Fatigue Scale scores from baseline at the end of 2, 4, and 8 weeks of treatment. | The scale ranges from 0 to 4, with lower scores indicating better outcomes. |
| BFI | BFI differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment | The scale ranges from 0 to 10, with lower scores indicating better outcomes. |
| FACT-Lym total score | FACT-Lym total score differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment | The scale ranges from 0 to 4, with lower scores indicating better outcomes. |
Countries
China
Contacts
Primary ContactQingqing Cai
Outcome results
None listed