Xinlikang Capsule for Chemotherapy-induced Fatigue and Immune Disorders in Diffuse Large B Lymphoma

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Xinlikang Capsule in the Treatment of Chemotherapy-induced Fatigue and Immune Disorders in Patients With Diffuse Large B Lymphoma

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

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.