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A prospective, single arm, real-world study of Xinlikang capsules in the treatment of cancer-related fatigue in patients with malignant tumors in the rehabilitation stage

A prospective, single arm, real-world study of Xinlikang capsules in the treatment of cancer-related fatigue in patients with malignant tumors in the rehabilitation stage

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086399
Enrollment
Unknown
Registered
2024-07-01
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer-related fatigue

Interventions

Trial group:This study is an observational study and will not involve additional interventions for patients.

Sponsors

Hunan Institute of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Between the ages of 18 and 75, regardless of gender; 2. Meets the diagnostic criteria for malignant tumors; 3. Completed surgery, radiation and chemotherapy for more than one month, and had no surgery, radiation and chemotherapy plans during the trial period; 4. Meets the diagnostic criteria for CRF; 5. The fatigue level screening scale (Piper Fatigue Survey Scale) scores = 4 points; 6. KPS = 60 points; 7. Expected survival time = 6 months; 8. Having normal mental consciousness, able to correctly understand the content of the survey questionnaire and independently fill it out; 9. All participants included in this study were informed and fully agreed to the content and project of this study.

Exclusion criteria

Exclusion criteria: 1. Individuals who are allergic or intolerant to Xinlikang capsules or their formulations; 2. Significant abnormalities in liver and kidney function: ALT ASTGGT=1.5 ULN;BUNCr=1.5 ULN; 3. Significant abnormalities in bone marrow function: white blood cells = 2.0 x 10 ^ 9/L, neutrophils = 1.5 x 10 ^ 9/L, platelets = 100 x 10 ^ 9/L, hemoglobin = 90g/L; 4. The main organs such as the heart, lungs, and digestive tract suffer from non cancerous serious diseases and functional impairments, such as myocardial infarction, uncontrolled angina, obvious ventricular arrhythmias, and severe heart failure; Severe respiratory depression and hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, pulmonary heart disease, and severe bronchial asthma; Severe viral infection and septic shock; Patients with immune related diseases and hematological disorders; 5. Unable to understand and correctly complete the rating scale; 6. Pregnant women, lactating women, and individuals with mental confusion; 7. Participants in other clinical trials within the past month; 8. Take other traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction to relieve fatigue during treatment; 9. Other patients deemed unsuitable for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
The Cancer related Fatigue Scale adopts the Piper Fatigue Scale;

Secondary

MeasureTime frame
EORTC QLQ-C30 v3.0;Adverse Events;Karnofsky Scale;Routine blood test;Liver and kidney function;Electrolyte;Routine urine test;Stool routine;

Countries

China

Contacts

Public ContactQimei WANG

Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine Research Institute

94082238@qq.com+86 138 7315 7532

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026