Cancer-related Fatigue
Conditions
Interventions
Treatment Group:Fuzheng Quxie prescription (Yifei Sanjie prescription) combined with postoperative adjuvant chemotherapy
Control Group:Fuzheng Quxie prescription (Yifei Sanjie prescription) placebo combined with postoperative adjuvant chemotherapy
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with non-small cell lung cancer by surgical pathology and cytology with TMN stage IIA to IIIA and at least one course of postoperative adjuvant chemotherapy had not received radiotherapy. (2) Meet the diagnostic criteria of ICD10 CRF; (3) Driver gene negative (no EGFR, ALK, ROS1 mutation); (4) patients aged 18-75 years; (5) Individuals must have conscious and cognitive ability to evaluate their feelings subjectively; (6) Tumor PS score <=2, no other serious complications; (8) I agreed to participate in the study after being informed, signed the informed consent, and the compliance is good; (9) non-pregnant and lactating patients; (10) No allergic reaction to the prescription ingredients.
Exclusion criteria
Exclusion criteria: (1) Patients with cancer recurrence and metastasis; (2) Conditions that may prevent subjects from completing the clinical trial process, including but not limited to serious and difficult to control organic disease or infection, heart failure, etc.; Patients with severe hepatic and renal dysfunction (serum creatinine >=1.5 ULN; ALT or AST>= 5*ULN; Bilirubin >=1.5*ULN); (3) Patients with hematopoietic diseases, such as anemia, who need to use anemia correction drugs; (4) Patients who are receiving or are about to receive treatment that may have an impact on CRF; (5) patients who are using other drugs that may improve CRF; (6) Complicated with tumors of other systems; (7) Patients with mental illness and lack of autonomous behavior ability; (8) Subjects considered by the investigator to be unable to cooperate with the completion of the clinical investigation (9) women who are pregnant, planning to become pregnant or breastfeeding; Patients who are participating in another clinical trial or have participated in another clinical trial within 3 months; (10) alcoholics and/or psychoactive substances, drug abusers and dependent persons; (11) Other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, could easily cause the loss of follow-up, according to the judgment of the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PiperFatigueScale,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;Overall survival, OS;Pittsburgh Sleep Quality Index, PSQI;EORTC QLQ-LC43; | — |
Countries
China
Contacts
Public ContactTian Jianhui
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed