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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)

Treatments: Drug: mimic capsules; Drug: Xinlikang capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT07084662

B2025-004

Details and patient eligibility

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Xinlikang capsules

Experimental group

Description:

The experimental group was treated with Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks.

Treatment:

Drug: Xinlikang capsules

Mimic capsules

Placebo Comparator group

Description:

The control group was treated with mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks.

Treatment:

Drug: mimic capsules