Cancer-related fatigue
Conditions
Interventions
Xinlikang capsule group:Xinlikang capsule is taken orally after meals 5 capsules (450mg/ capsule) each time 3 times a day for 8 weeks
Placebo group:Xinlikang simulator is taken orally after meals 5 capsules (450mg/ capsule) each time 3 times a day for 8 weeks
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet the following criteria to be enrolled in the study: 1) Age 18-75; 2) Patients with histopathological diagnosis of lung cancer breast cancer or colorectal cancer; 3) Patients who have undergone surgical resection of the primary lesion and completed postoperative adjuvant radiotherapy adjuvant chemotherapy or adjuvant chemoradiotherapy according to the corresponding guidelines ; 4) Patients who have completed postoperative adjuvant radiotherapy adjuvant chemotherapy or adjuvant chemoradiotherapy at least 1 month before screening; 5) Patients who meet the criteria of cancer-related fatigue (CRF) in China's Clinical Practice Guidelines for Cancer Related Fatigue (2021 Edition) that is the following symptoms or conditions occur every day or almost every day for 2 weeks or more in the past month: (1) Significant fatigue at the most recent activity level physical or need for more rest accompanied by five or more of the following symptoms: 1) general weakness 2) inability to concentrate 3) low mood 4) insomnia or lethargy 5) fatigue after rest 6) difficulty in activities 7) emotional response 8) inability to complete daily activities 9) memory loss 10) fatigue symptoms continue to fail to relieve; (2) The clinical symptoms cause significant distress and impairment in social occupational or other important functional areas; (3) Have a history physical examination report and laboratory test report showing that CRF symptoms are caused by cancer or cancer treatment; (4) CRF symptoms are not primarily due to mental disorders associated with the tumor and its treatment such as severe depression somatic disorders or delirium; 6) Brief Fatigue Inventory (BFI) score =4 points; 7) Patients with no surgery radiotherapy or chemotherapy plan for at least 1 month before enrollment and during this clinical trial; 8) Patients with no other treatment for cancer-related fatigue and anemia including drug and non-drug therapy for at least 1 month before enrollment and during the clinical trial; 9) KPS=60 points; 10) Expected survival =6 months; 11) Patients who agree to use effective contraceptive methods without conceiving or causing another person to conceive during the trial and for one month after completion of the trial; 12) Patients with normal mental consciousness to correctly understand the contents of the questionnaire and fill in the questionnaire independently; 13) Patients who voluntarily participate in clinical trials and sign informed consent and the signing of informed consent is in line with the requirements of the clinical trial Management Practice (GCP).
Exclusion criteria
Exclusion criteria: Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria: 1) Metastatic or recurrent patients; 2) Patients who received other anti-tumor therapy except radiotherapy and chemotherapy after surgery; 3) Patients who are allergic to or intolerant of Xinlikang capsule or its component drugs; 4) Patients with abnormal liver and kidney function: ALT AST GGT=3 ULN; BUN Cr=3 ULN; 5) Patients with significantly abnormal bone marrow function: leukocytes =2.0×10^9/L neutrophils =1.0×10^9/L platelets =50×10^9/L; 6) Patients with non-neoplastic serious diseases and dysfunctions of the heart lungs gastrointestinal tract and other major organs as judged by the clinician including but not limited to myocardial infarction uncontrolled angina pectoris significant ventricular arrhythmia severe heart failure; severe respiratory depression with hypoxia and/or hypercapnia severe COPD cor pulmonale severe bronchial asthma; severe viral infections and infections Toxic shock; immune-related diseases and hematologic disorders;; 7) Patients with fatigue from other sources such as hypothyroidism decompensated heart failure chronic obstructive pulmonary disease requiring oxygen etc. 8) Patients who need to receive treatment for anemia; 9) Patients who need to use ginseng drugs or other complementary Chinese and chemical drugs to treat cancer-related fatigue; 10) Patients with poorly controlled depression defined as a change in antidepressant type or dose in the 14 days prior to screening; 11) Patients with poorly controlled pain defined as a change in the type or dose of analgesic medication in the 14 days prior to screening; 12) Patients with poorly controlled hypertension: systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg; 13) Patients with poorly controlled diabetes: blood glucose value > 11.1mmol/L at any time during the 14 days before screening; 14) Patients combined with other tumors; 15) Patients who participate in other clinical trials within 30 days before screening or during this trial; 16) Patients who were considered inappropriate in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Piper score on the cancer-related fatigue scale (Piper Fatigue Scale); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological indexes: WBC RBC Hb PLT ALB CRP;Change from baseline in Piper score on the cancer-related fatigue scale (Piper Fatigue Scale);Proportion of patients with moderate to severe fatigue as assessed by Piper score;Quality of Life Scale Score changes (EORTC QLQ-C30 v3.0 Chinese version);TBNK lymphocyte detection: NK CD3+ CD4+ CD8+ absolute count and relative count CD4+/CD8+ ratio;Changes in BFI score;Changes in KPS score;Twelve cytokines and difference from baseline: IL-1ß IL-2 IL-4 IL-5 IL-6 IL-8 IL-10 IL-12 IL-17 TNF-a IFN-a IFN-?; | — |
Countries
China
Contacts
Public ContactZan Shen
Shanghai Sixth People's Hospital
Outcome results
None listed