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A prospective single-arm study: Shen-Qi-Gui in the treatment of cancer-related fatigue (CRF)

Shen-Qi-Gui in the treatment of cancer-related fatigue (CRF): a prospective single-arm study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004616
Enrollment
Unknown
Registered
2021-03-23
Start date
2021-04-01
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

cancer-related fatigue

Interventions

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with stage IV lung cancer diagnosed by pathology; 2) Patients requiring chemotherapy; 3) Patients receiving platinum-containing two-drug regimens chemotherapy and is expected to receive four more cycles of regimens chemotherapy in the future; 4) The scores of tumor patients on the subjective fatigue level screening scale were >= 4 points; 5) Normal cognitive function and able to independently complete the questionnaire related to the research; 6) Hematology, liver and kidney functions and important organ functions meet the requirements of chemotherapy; 7) No obvious obstacle in swallowing function, able to take the study drugs orally smoothly; 8) Informed and consented to participate in the clinical trial, and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients have other exact causes of fatigue (such as hypothyroidism, insomnia, uncontrolled pain, moderate to very severe anemia, severe malnutrition, cachexia, etc.); 2) Patients who have been using or are allergic to renal qi GUI, or have a history of drug-induced liver injury. 3) Patients are already taking prescription stimulants or other drugs/health care products with clearly marked anti-fatigue effects; 4) Patients with other types of cancer and tumor stage other than stage IV; 5) Complicated mental disorders (anxiety, bipolar disorder, obsessive-compulsive disorder, schizophrenia), acute or chronic progressive or unstable neurological states (dementia, delirium, or epilepsy); Cognitive dysfunction; 6) Other diseases requiring treatment with glucocorticoids (excluding chemotherapy pretreatment); 7) Patients with poor compliance and are not expected to complete the study as planned; 8) Pregnant or lactating women; 9) Patients with hypertensive crisis, diabetic ketoacidosis, serious liver diseases such as decompensation of cirrhosis and severe renal insufficiency.

Design outcomes

Primary

MeasureTime frame
Piper fatigue scale;

Countries

China

Contacts

Public ContactWeigang Xiu

West China Hospital of Sichuan University

123544361@qq.com+86 15982378768

Outcome results

None listed

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