Introduction:Chemotherapy-induced gastrointestinal symptom clusters in breast cancer impair quality of life and treatment adherence,yet lack effective interventions.While acupuncture mitigates isolated chemotherapy-in...Introduction:Chemotherapy-induced gastrointestinal symptom clusters in breast cancer impair quality of life and treatment adherence,yet lack effective interventions.While acupuncture mitigates isolated chemotherapy-induced symptoms,its mechanisms for multi-symptom clusters remain unclear.This study evaluates electroacupuncture's efficacy and explores its biological mechanisms in managing these clusters.Methods:This prospective,multicenter,block-randomized,double-blind,sham-controlled trial will enroll 388 patients with breast cancer undergoing neoadjuvant/adjuvant chemotherapy,to be randomly assigned(1:1)to electroacupuncture or sham electro-acupuncture groups.Both groups will receive the standard quadruple antiemetic regimen combined with electroacupuncture or sham intervention.The primary endpoint is the incidence of chemotherapy-induced gastrointestinal symptom clusters within 120 h after chemotherapy.Secondary endpoints include improvement in gastrointestinal symptom clusters post-first chemotherapy cycle,nausea-free rates during acute and delayed phases,vomiting-free rates during overall,acute,and delayed phases,complete response rate,complete protection rate,and quality of life.Adverse events will be documented throughout the study.Discussion:This study will assess the efficacy and safety of electroacupuncture in alleviating chemotherapy-induced gastro-intestinal symptom clusters in patients with breast cancer.By integrating multi-omics analyses,we aim to elucidate the biological mechanisms underlying its therapeutic effects.The findings may offer a robust clinical foundation for optimizing symptom cluster management in cancer care.Trial Registration:Clinical Trials ID:NCT06952920.Date of registration:April 16,2025.Prospectively registered.URL of Trial Registry Record:https://clinicaltrials.gov/study/NCT06952920cond=NCT06952920&rank=1.展开更多
We aimed to evaluate the efficacy and safety of adding apatinib,to sintilimab and chemotherapy in the neoadjuvant treatment of early triple-negative breast cancer(TNBC).In the phase 2 NeoSAC trial,patients with early ...We aimed to evaluate the efficacy and safety of adding apatinib,to sintilimab and chemotherapy in the neoadjuvant treatment of early triple-negative breast cancer(TNBC).In the phase 2 NeoSAC trial,patients with early TNBC received six cycles of apatinib,sintilimab,nab-paclitaxel,and carboplatin followed by surgery.The primary endpoint was pathological complete response(pCR)rate.Specimens collected pre-neoadjuvant therapy and post-surgery were retained for comprehensive analysis of predictive biomarkers and the impact on the tumor microenvironment.Among 34 enrolled patients,24 achieved pCR(70.6%;95%confidence interval(CI),53.0-85.3),and 79.4%(95%CI,65.1-93.7)had residual cancer burden 0-I.Imaging evaluation showed 21 complete responses(61.8%)and 13 partial responses(38.2%).The most common grade 3-4 adverse events were leukopenia(47%),neutropenia(36%),and thrombocytopenia(24%).The 36-month disease-free survival rate stood at 94.1%with a median follow-up of 39.1 months.Notably,baseline high ImmuneScore,immune cell infiltration,and enrichment of interferon-related pathways correlated with pCR.Comparison of pre-neoadjuvant and post-surgery data revealed that the pCR group treated with this novel regimen exhibited an upregulation of distinct immune cell subsets,thereby activating the tumor microenvironment.Moreover,higher oxeiptosis scores were associated with an increased likelihood of achieving pCR.Following neoadjuvant therapy,the pCR group showed a decrease in oxeiptosis score,whereas the non-pCR group exhibited an increase.Our study suggests that apatinib,sintilimab combined with carboplatin and nab-paclitaxel chemotherapy showed a promising clinical activity and manageable safety profile in early TNBC and merits further study.ClinicalTrials.gov registration:NCT04722718.展开更多
基金Noncommunicable Chronic Diseases-National Science and Technology Major Project,Grant/Award Numbers:2024ZD0521400,2024ZD0521404Affiliated Hospital of Qinghai University。
文摘Introduction:Chemotherapy-induced gastrointestinal symptom clusters in breast cancer impair quality of life and treatment adherence,yet lack effective interventions.While acupuncture mitigates isolated chemotherapy-induced symptoms,its mechanisms for multi-symptom clusters remain unclear.This study evaluates electroacupuncture's efficacy and explores its biological mechanisms in managing these clusters.Methods:This prospective,multicenter,block-randomized,double-blind,sham-controlled trial will enroll 388 patients with breast cancer undergoing neoadjuvant/adjuvant chemotherapy,to be randomly assigned(1:1)to electroacupuncture or sham electro-acupuncture groups.Both groups will receive the standard quadruple antiemetic regimen combined with electroacupuncture or sham intervention.The primary endpoint is the incidence of chemotherapy-induced gastrointestinal symptom clusters within 120 h after chemotherapy.Secondary endpoints include improvement in gastrointestinal symptom clusters post-first chemotherapy cycle,nausea-free rates during acute and delayed phases,vomiting-free rates during overall,acute,and delayed phases,complete response rate,complete protection rate,and quality of life.Adverse events will be documented throughout the study.Discussion:This study will assess the efficacy and safety of electroacupuncture in alleviating chemotherapy-induced gastro-intestinal symptom clusters in patients with breast cancer.By integrating multi-omics analyses,we aim to elucidate the biological mechanisms underlying its therapeutic effects.The findings may offer a robust clinical foundation for optimizing symptom cluster management in cancer care.Trial Registration:Clinical Trials ID:NCT06952920.Date of registration:April 16,2025.Prospectively registered.URL of Trial Registry Record:https://clinicaltrials.gov/study/NCT06952920cond=NCT06952920&rank=1.
基金funded by the Provincial-Level Clinical Key Specialty Construction in Qinghai Province in China.
文摘We aimed to evaluate the efficacy and safety of adding apatinib,to sintilimab and chemotherapy in the neoadjuvant treatment of early triple-negative breast cancer(TNBC).In the phase 2 NeoSAC trial,patients with early TNBC received six cycles of apatinib,sintilimab,nab-paclitaxel,and carboplatin followed by surgery.The primary endpoint was pathological complete response(pCR)rate.Specimens collected pre-neoadjuvant therapy and post-surgery were retained for comprehensive analysis of predictive biomarkers and the impact on the tumor microenvironment.Among 34 enrolled patients,24 achieved pCR(70.6%;95%confidence interval(CI),53.0-85.3),and 79.4%(95%CI,65.1-93.7)had residual cancer burden 0-I.Imaging evaluation showed 21 complete responses(61.8%)and 13 partial responses(38.2%).The most common grade 3-4 adverse events were leukopenia(47%),neutropenia(36%),and thrombocytopenia(24%).The 36-month disease-free survival rate stood at 94.1%with a median follow-up of 39.1 months.Notably,baseline high ImmuneScore,immune cell infiltration,and enrichment of interferon-related pathways correlated with pCR.Comparison of pre-neoadjuvant and post-surgery data revealed that the pCR group treated with this novel regimen exhibited an upregulation of distinct immune cell subsets,thereby activating the tumor microenvironment.Moreover,higher oxeiptosis scores were associated with an increased likelihood of achieving pCR.Following neoadjuvant therapy,the pCR group showed a decrease in oxeiptosis score,whereas the non-pCR group exhibited an increase.Our study suggests that apatinib,sintilimab combined with carboplatin and nab-paclitaxel chemotherapy showed a promising clinical activity and manageable safety profile in early TNBC and merits further study.ClinicalTrials.gov registration:NCT04722718.
