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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• The difference of FACIT Fatigue Scale score [Срок оценки: From baseline to 12 weeks of treatment]

Вторичные конечные точки (3)

• The difference of FACIT Fatigue Scale scores [Срок оценки: Differences in FACIT Fatigue Scale scores from baseline at the end of 2, 4, and 8 weeks of treatment.]
• BFI [Срок оценки: BFI differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment]
• FACT-Lym total score [Срок оценки: FACT-Lym total score differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT07084662 · B2025-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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