Cancer-related fatigue after chemotherapy
Conditions
Interventions
Experimental group:Lu Dangshen Oral Liquid
Control group:Ludangshen oral liquid simulant
Sponsors
Beijing University of Chinese Medicine Dongfang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with malignant tumors diagnosed by pathology or cytology (breast cancer, lung cancer, gastric cancer, colorectal cancer, ovarian cancer); (2) Those who are enrolled within 14 days after completing the radiotherapy cycle (25-30 times for breast cancer, 25-35 times for lung cancer, 25-30 times for gastric cancer, 25-30 times for colorectal cancer, 5-10 times for ovarian cancer) and the first-line chemotherapy cycle (4-6 cycles for breast cancer, 4-6 cycles for lung cancer, 6-8 cycles for gastric cancer, 8-12 cycles for colorectal cancer, 3-6 cycles for ovarian cancer); (3) Those who meet the diagnostic criteria for cancer-related fatigue; (4) Piper Fatigue Scale Revised (PFS-R) score =4 (moderate to severe fatigue); (5) Those who meet the TCM diagnostic criteria for spleen and lung Qi deficiency syndrome; (6) ECOG score of 0-2; (7) Expected survival time =3 months; (8) Aged 18 to 75 years (inclusive of 18 and 75 years), regardless of gender; (9) Voluntarily participating in this clinical trial, informed consent, and signing the written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients undergoing neoadjuvant radiotherapy, chemotherapy, or chemoradiotherapy before surgery; (2) Those experiencing fatigue due to excessive exertion; (3) Patients with other diseases that may cause fatigue, such as muscular dystrophy, uncontrolled metabolic diseases (like diabetes), decompensated heart failure, chronic obstructive pulmonary disease requiring oxygen, etc.; (4) Those with hemoglobin 3 times the upper limit of normal reference values, or serum creatinine (Scr) > 2 times the upper limit of normal reference values; (10) Pregnant or breastfeeding women; (11) Those known to be allergic to the investigational drug or with contraindications; (12) Those who participated in other clinical trials within 1 month prior to randomization; (13) Researchers deeming them unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the change in Piper Fatigue Scale-Revised (PFS-R) scores in Week 4.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Week 2 Piper Fatigue Scale-Revised (PFS-R) score change values;Change values and efficacy rate of TCM syndrome scores in week 2;The effective rate of single symptoms in the 2nd and 4th weeks (fatigue, low voice, shortness of breath, spontaneous sweating, loss of appetite, abdominal distension, loose stools, pale complexion);ECOG score changes in week 2 and week 4;Changes in clinical symptoms/Traditional Chinese Medicine (TCM) syndrome scores and efficacy rate at Week 4.;Single symptom efficacy rate in week 4 (fatigue and lack of energy, low voice and reluctance to speak, shortness of breath, spontaneous sweating, poor appetite, abdominal distension, loose stools, pale and lackluster complexion);Clinical Symptoms Change Values and Efficacy Rate for Week 2; | — |
Countries
China
Contacts
Public ContactKaiwenHu QuanwangLi
Beijing University of Chinese Medicine Dongfang Hospital
Outcome results
None listed