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A randomized, controlled, open, multi-center clinical study on the effectiveness and safety of Kangai injection in the treatment of cancer-induced fatigue

A randomized, controlled, open, multi-center clinical study on the effectiveness and safety of Kangai injection in the treatment of cancer-induced fatigue

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004974
Enrollment
Unknown
Registered
2021-02-25
Start date
2021-03-31
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Tumor patients (lung cancer, rectal cancer, malignant lymphoma, gynecological malignancy)

Interventions

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Determined by histopathology or cytology as a tumor patient (lung cancer, rectal cancer, malignant lymphoma, gynecological malignant tumor); 2. Patients receiving chemotherapy; 3. ECOG score 0-1 points; 4. Meet the diagnostic criteria for cancer-related fatigue, and have a fatigue score >=4 (using a 0-10 numerical scale to score the degree of fatigue, 0 = no fatigue, 10 = the most severe fatigue); 5. Age from 18 to 80 years old; 6. Voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. People with severe mental disorders; 2. People with speech and cognitive impairment; 3. People with allergies or known to be allergic to the drugs and their ingredients used in this test; 4. Patients with abnormal liver and kidney function indexes (ALT, AST, Scr exceed the upper limit of the normal reference range by 1.5 times); 5. Pregnant and lactating women, or women of childbearing age whose blood and/or urine HCG test results are positive before the test; 6. Patients with poor compliance; 7. Other patients who the investigator thinks are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Piper Fatigue Scale;

Secondary

MeasureTime frame
KPS score;Immune function;Quality of life (EORTC-QLQ-C30);Peripheral blood;Incidence of side effects of chemotherapy;

Countries

China

Contacts

Public ContactShu Peng

Jiangsu Provincial Hospital of Traditional Chinese Medicine

240516590@qq.com+86 13851701678

Outcome results

None listed

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