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

NCT07084662 | Recruiting Phase 2

• 1 other identifier: B2025-004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

• The difference of FACIT Fatigue Scale score

  The scale ranges from 0 to 4, with lower scores indicating better outcomes.

  From baseline to 12 weeks of treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Xinlikang capsules

EXPERIMENTAL

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

Drug: Xinlikang capsules

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.

Drug: mimic capsules

Interventions

Xinlikang capsules DRUG

Xinlikang capsules after meals, 5 capsules each time, 3 times a day for 12 weeks

Xinlikang capsules

mimic capsules DRUG

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

Mimic capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

tebufenozide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Qingqing Cai

CONTACT

02087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 24, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: November 26, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)