NCT07084662招募中2 期
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
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月11日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The difference of FACIT Fatigue Scale score
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Xinlikang capsules
Experimental
The experimental group was treated with Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks.
干预措施: Xinlikang capsules (Drug)
Mimic capsules
Placebo Comparator
The control group was treated with mimic capsules, 5 capsules each time after meals, 3 times a day for 12 weeks.
干预措施: mimic capsules (Drug)
结局指标
主要结局
The difference of FACIT Fatigue Scale score
时间窗: From baseline to 12 weeks of treatment
The scale ranges from 0 to 4, with lower scores indicating better outcomes.
次要结局
- The difference of FACIT Fatigue Scale scores(Differences in FACIT Fatigue Scale scores from baseline at the end of 2, 4, and 8 weeks of treatment.)
- BFI(BFI differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment)
- FACT-Lym total score(FACT-Lym total score differences from baseline at 2 weeks, 4 weeks, 8 weeks and 12 weeks of treatment)
研究者
Qingqing Cai
MD. PhD.
Sun Yet-Sen University Cancer Center
研究点 (1)
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