Actively Recruiting
Xinlikang Capsule for Chemotherapy-induced Fatigue and Immune Disorders in Diffuse Large B Lymphoma
Led by Sun Yat-sen University · Updated on 2025-11-26
80
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Xinlikang Capsule for Chemotherapy-induced Fatigue and Immune Disorders in Diffuse Large B Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Newly diagnosed with diffuse large B-cell lymphoma (DLBCL)
- Completed first-line chemotherapy and immunotherapy treatment
- Achieved metabolic complete response confirmed by PET/CT during or after chemotherapy
- Completed full chemotherapy regimen 30 to 90 days prior
- Fatigue score of 4 or higher on the BFI scale
- Expected survival time of at least 6 months
- No plans for CD20 monoclonal antibody, radiotherapy, chemotherapy, lenalidomide, thymopeptides, targeted drugs, biological agents, immunosuppressants, or other Chinese medicine treatments for the next 3 months
- No planned major surgery (grade 3-4) in the next 3 months
- Mentally alert and able to understand and complete questionnaires independently or with assistance
- Women and men of childbearing potential agree to use contraception during treatment and for 1 month after
- Voluntary participation with signed informed consent following Good Clinical Practice (GCP) guidelines
You will not qualify if you...
- DLBCL patients with central nervous system involvement at initial diagnosis
- Allergy or intolerance to Xinlikang capsules or its ingredients
- Significant abnormal liver or kidney function (ALT, AST, GGT, BUN, Cr above 3 times upper limit of normal)
- Severe bone marrow dysfunction (low white blood cells, neutrophils, platelets, or hemoglobin below specified thresholds)
- HIV infection, bacterial infection, or other immune diseases affecting immune function
- Uncontrolled hepatitis B or C infection as defined by viral load tests
- Presence of other cancers
- Participation in another clinical trial within 30 days before screening or during this trial
- Investigator judgment deeming patient ineligible for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qingqing Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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