Cancer-related fatigue
Conditions
Interventions
Experimental Group:Compound Ejiao Extract (Specification: 20ml per vial), Dosage and Administration: Oral administration, 20ml per dose, three times daily
start on the first day of chemotherapy.
Control Group:Compound Ejiao Oral Liquid Simulator (Specification: 20ml per bottle), Dosage and Administration: Oral, 20ml per dose, three times daily
to be started on the first day of chemotherapy.
Sponsors
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)18 years = age = 75 years, gender; (2)Confirmed pathological diagnosis of gastric cancer or colorectal cancer, with ECOG PS < 2 points; (3)Gastric cancer or colorectal cancer pTNM stage II or III; (4)Have undergone tumor resection surgery, have completed 2 cycles of adjuvant chemotherapy after surgery, and are assessed by an oncologist to require at least =2 more cycles of adjuvant chemotherapy; (5) Meet the diagnostic criteria for cancer-related fatigue in Western medicine, with an average score =4 on the Piper Fatigue Revised Scale at screening; (6)Meet the diagnostic criteria for deficiency of both qi and blood in traditional Chinese medicine; (7)Main laboratory examination indicators meet the following conditions: 1) Blood routine: WBC = 3.0x10^9/L or NEUT = 1.5x10^9/L, HGB = 100 g/L, PLT = 100.0x10^9/L; 2) Liver function: TBIL = 1.5xULN, AST and ALT = 2.5xULN, and ALP = 3xULN; ALB = 3 g/dL; 3) INR = 1.5xULN, PT = 1.5xULN, APTT = 1.5xULN; 4) Renal function: Scr = 1.5xULN and estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula =60 ml/min/1.73m²; (8)Expected survival =6 months; (9)Voluntarily participate and be able to cooperate with the investigator to conduct this trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) At screening, BMI 8%) or severe diabetic complications, such as proliferative diabetic retinopathy, history of kidney transplantation, or severe peripheral vascular disease (e.g., leading to amputation, chronic foot ulcers, or intermittent claudication); (12) Experienced acute myocardial infarction within 3 months prior to screening, or has unstable angina, arrhythmia requiring treatment, or severe heart failure (NYHA functional classification = III), as assessed by the investigator to be unsuitable for participation in this clinical trial; (13) Experienced a new cerebrovascular event (e.g., ischemic stroke, hemorrhagic stroke, or transient ischemic attack) within 3 months prior to screening, as assessed by the investigator to be unsuitable for participation in this clinical trial; (14) Has other severe systemic diseases that, in the investigator's judgment, may affect the assessment of the efficacy or safety of the investigational product, including diseases of the respiratory, digestive, hepatic, renal, or hematologic systems; (15) Experienced major trauma requiring surgical intervention within 4 weeks prior to screening; (16) Has severe depression (SDS standard score = 70), severe anxiety (SAS standard score = 70), schizophrenia, or other severe mental disorders, or is judged by the investigator to require treatment with anxiolytics or antidepressants; or has malignancies at other sites (excluding adequately treated cervical carcinoma in situ, skin basal cell carcinoma, or other tumors cured by surgery with no recurrence for at least 5 years); (17) Known or suspected allergy to Ejiao oral liquid or its components; (18) History of alcohol or substance abuse within 1 year prior to screening; (19) Known pregnancy (confirmed at screening via pregnancy test), women planning to become pregnant or breastfeeding during the study, or fertile men or women unwilling to use reliable contraception from screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean score change from baseline of the Piper Fatigue Revised Scale during treatment from 1 week to 6 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in FACT-F scale scores after 3 weeks and 6 weeks of treatment compared to baseline.;Change in BFI scores from baseline at week 3 and week 6 of treatment.;Change in hemoglobin (HGB) from baseline at 3 and 6 weeks of treatment.;The changes in Chinese Medicine (CM) symptom total scores and individual symptom scores after 3 weeks and 6 weeks of treatment compared to baseline values.;Grip strength change from baseline at 3 and 6 weeks of treatment.;Adverse Events ;Vital Signs (Temperature, Pulse, Respiration, Blood Pressure);Physical Examination (Skin and Mucous Membranes, Lymph Nodes, Head and Neck, Chest, Abdomen, Spine/Limbs/Joints, Nervous System, Other Areas).;Laboratory Tests 1) Blood Routine (RBC, WBC, NEUT, HGB, HCT, PLT); 2) Urinalysis (PRO, GLU) + Microscopic Examination of Sediment (LEU, ERY); 3) Liver Function (ALT, AST, ALP, DBIL, TBIL, Y-GT, ALB); 4) Renal Function (Scr, UreaBUN);;12-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactJun Zhang
Shanghai Jiao Tong University Affiliated Ruijin Hospital
Outcome results
None listed