| Objective:Cancer-related fatigue is an important factor affecting the quality of life of patients with advanced colorectal cancer.Improving the quality of life,especially the symptom of cancerrelated fatigue,is a difficult and urgent problem in the study of advanced colorectal cancer.This study was designed to investigate the improvement of cancer-related fatigue in patients with advanced colorectal cancer by Huang Ci-formulas,a traditional Chinese medicine compound with the function of tonifying kidney and detoxifying,and explore its mechanism.Methods:A prospective,randomized controlled,double-blind,designed study of patients with advanced colorectal cancer who were scheduled for chemotherapy between July 1,2016 and December 31,2018,who were diagnosed with cancer-related fatigue according to random numbers.The patients were divided into treatment group and control group.The treatment group received chemotherapy combined with Huang Ci-formulas,while control group received chemotherapy combined with placebo to continue treatment until the disease progressed or could not tolerate further treatment.The fatigue scale(Piper fatigue scale and BFI-C fatigue scale)score,KPS score,quality of life EORTC QLQ-C30 score,total score of TCM symptom,progression-free survival and its independent influencing factors,the physical and chemical indicators(tumor markers,cytokines,cellular immunity,HPA axis levels)were compared between the two groups to investigate the improvement of cancer-related fatigue and evaluate the safety of Huang Ci-formulas.Results:From July 1,2016 to December 31,2018,inpatient and outpatient Department in oncology and general surgery of Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine: Diagnosed with stage IV colorectal cancer,in accordance with the diagnosis of cancer-related fatigue,patients undergoing chemotherapy treatment.A total of 72 patients were enrolled in the screening criteria,of which 64 were included in the analysis.The treatment group completed 32 follow-up and the control group completed 32 follow-up.The results were as follows:(1)Evaluated by the Piper fatigue scale,and the fatigue in behavior,emotion,somatic sensation,cognitive emotion and in total fatigue scores were improved after treatment.Furthermore,the improvement of fatigue in the treatment group was more significant(P<0.0001)and the improvement of cognitive mood fatigue was most pronounced in four fatigue dimensions(P<0.0001).The improvement rate of fatigue total score of treatment group was up to 100%,while the improvement rate in control group was only90.63%.Evaluated by the BFI-C scale,the treatment group significantly improved the degree of fatigue,past 24h fatigue,past 24h fatigue’s impact on mood,walking,work,relationships with others and the pleasures of life(P<0.0001).The improvement rate of fatigue in the treatment group was 93.75%,while that of the control group was only 28.13%,the improvement rate of the previous 24h fatigue was 96.88%in the treatment group,and the control group was only 31.25%.In the past,24h fatigue had the most obvious improvement on the relationship between others in all aspects of life.The improvement rate in the treatment group was 90.63%,compared with 25%in the control group.(2)The improvement rate of physical condition KPS score in treatment group was up to 50%,while that in control group was only 31.25%(P=0.02<0.05).(3)The quality of life EORTC QLQ-C30 scores in the treatment group could be significantly improved among‘somatic function’(P<0.0001),‘Emotional function’(P=0.0031<0.05)and‘tiredness’(P<0.0001).(4)In the treatment group,the total curative effect of TCM symptom quantification was up to 84.38%,the control group was only 31.25%,and the curative effect was statistically different(P=0.0002<0.01).And according to the basic symptoms of the syndrome in two groups of patients,according to TCM symptom level clustering Analysis,can be divided into three categories:abdominal pain,stool mucus pus,bitter mouth,dizziness tinnitus,urine yellow,insomnia,waist and knee sour,abdominal block refused to press,bowel,face yellowish,chills,cold limbs,diarrhea,abdominal distension,bad appetite.(5)The treatment group m PFS(median progression-free survival)was 7.13 months and the control group m PFS was 4.47 months.The treatment group was significantly longer than that of the control group(P=0.0357<0.05,HR=0.61(95%CI:0.37-1.00)).Cox regression analysis was further used to find that the treatment method was an independent factor affecting the progression-free survival(P=0.023<0.05),patients with advanced colorectal cancer treated with Huang granules have a lower risk of progression than patients using a placebo,HR=0.550(95%CI:0.326-0.926).The number of metastases is also an independent factor affecting it(P=0.024<0.05),and there is a higher risk of progression in patients with multiple metastases than in patients with single metastases,HR=0.588(95%CI:0.332-0.988).(6)The improvement rate of common tumor markers,such as CEA,CA125 and CA724,in treatment group was higher than that in control group,but there was no significant difference in statistics(P>0.05).(7)The changes of inflammatory cytokines and cellular immunity before and after treatment were not obvious(P>0.05).(8)The level of ATCH before treatment was higher than that after treatment,while the CORT level was lower than that after treatment(P<0.05).Further using Pearson linear correlation analysis,it was found that the degree of cancer fatigue was related to ATCH intensity,showing a significant positive correlation trend(R=0.670,P<0.01),but weak correlation with CORT,the correlation was not obvious(R=0.337,P<0.05).(9)Application of Huang Ci-formulas is safe.The blood routine and blood biochemical basic stable distribution in the normal range,and the incidence of adverse reactions in this study is low,with I degree and second degree adverse reactions,the incidence of the adverse reactions of degree III and above is very low(P>0.05).Conclusion:Huang Ci-formulas can improve cancer-related fatigue,physical condition,quality of life,relieve clinical symptoms,effectively prolong progression-free survival,and have good safety in patients with advanced colorectal cancer and cancer-related fatigue.The improvement of cancer-related fatigue may be correlated with the regulation of HPA axis. |
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