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
Sun Yat-sen University
80 participants
Sep 11, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria12
- Age ≥18 years old;
- Newly diagnosed diffuse large B lymphoma (DLBCL);
- Patients had completed the first-line treatment of chemotherapy and immunotherapy and the course of treatment had been completed.
- Metabolic complete response (CR) was evaluated by PET/CT during or after chemotherapy.
- Had completed the full course of chemotherapy-containing regimen for more than 30-90 days;
- BFI fatigue score ≥4;
- The expected survival time was ≥6 months;
- 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;
- No grade 3-4 surgery plan is expected in the next 3 months;
- They had normal mental consciousness, could understand the content of the questionnaire correctly, and could complete the questionnaire with assistance or independently;
- Women and men of childbearing age agreed to use contraception during and for 1 month after treatment;
- 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 Criteria9
- DLBCL subjects with CNS involvement at initial diagnosis;
- Allergic or intolerant to Xinlikang capsule or its component drugs;
- Significant abnormal liver and kidney function: ALT, AST, GGT≥3 ULN; BUN and Cr≥3 ULN;
- 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;
- Patients with HIV virus infection, bacterial infection and other immune-related diseases that affect immune function as judged by clinicians;
- 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).
- Patients with other malignancies.
- Enrollment in another clinical trial 30 days before screening or during the trial;
- Persons who were deemed by the investigator to be ineligible to participate in the trial.
Interventions
Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks
mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07084662