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

Phase 1

Recruiting

Conditions: cancer-related fatigue

Registration Number: ITMCTR2100004616

Lead Sponsor: West China Hospital of Sichuan University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

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

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.