Xinlikang capsules for chemo-related fatigue and immune problems after DLBCL treatment

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

This trial will test whether Xinlikang capsules can reduce chemotherapy-related fatigue and improve peripheral blood lymphocyte counts in adults with diffuse large B-cell lymphoma who are in complete remission after first-line chemotherapy.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07084662 on ClinicalTrials.gov

What this trial studies

This phase 2/3 interventional study enrolls adults with newly diagnosed diffuse large B-cell lymphoma who have achieved a metabolic complete response by PET/CT after completing first-line chemotherapy. Eligible participants with significant fatigue (BFI ≥4) and at least 30–90 days since finishing chemotherapy are assigned to receive Xinlikang capsules or matching mimic capsules. The study measures changes in cancer-related fatigue and peripheral blood lymphocyte counts, along with monitoring safety and adverse events. Outcomes will determine whether Xinlikang improves symptoms and immune parameters compared with the mimic capsules.

Who should consider this trial

Good fit: Adults (≥18) with newly diagnosed DLBCL who have completed first-line chemotherapy, achieved metabolic complete remission by PET/CT, are 30–90 days post-chemotherapy, have a BFI fatigue score ≥4, and have an expected survival of at least 6 months are the intended participants.

Not a fit: Patients not in metabolic complete remission, still undergoing or planning further anti-cancer or immunosuppressive treatments within the next three months, or with low fatigue scores (BFI <4) are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, Xinlikang could lessen post-chemotherapy fatigue and help restore immune cell counts, improving quality of life for DLBCL survivors.

How similar studies have performed: Herbal and traditional medicine approaches have been explored for cancer-related fatigue, but high-quality randomized evidence specifically supporting Xinlikang for DLBCL-related fatigue and immune recovery is limited, making this approach relatively novel.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Qingqing Cai

Conditions Diffuse Large B-Cell Lymphoma