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Recruiting NCT07084662

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

Phase II / Phase III Interventional Diffuse Large B-Cell Lymphoma (DLBCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xinlikang capsules, mimic capsules.
Who it may be relevant to
Registry conditions: Diffuse Large B-Cell Lymphoma (DLBCL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Xinlikang capsules
    Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks
  • Drug mimic capsules
    mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks.

Primary outcome measures

  • The difference of FACIT Fatigue Scale score [Time frame: From baseline to 12 weeks of treatment]
Secondary outcome measures (3)
  • The difference of FACIT Fatigue Scale scores [Time frame: Differences in FACIT Fatigue Scale scores from baseline at the end of 2, 4, and 8 weeks of treatment.]
  • BFI [Time frame: BFI differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment]
  • FACT-Lym total score [Time frame: FACT-Lym total score differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT07084662 · B2025-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗