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 electroacupuncture 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 gastrointestinal 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.
Aim:This study aims to investigate the expression and function of antisense long non-coding RNA (lncRNA) STEAP3-AS1 in breast cancer (BC). Additionally, it explores STEAP3's regulatory relationship with STEAP3-AS1 and potential signaling pathways to provide a theoretical foundation for identifying novel therapeutic targets. Methods:Database prediction and collection of tissue samples were employed alongside a cell proliferation assay and Transwell migration and invasion assay to examine STEAP3-AS1 expression levels in BC tissues and cell lines, as well as its impact on cellular functions. Statistical analyses were performed, including two-tailed Student's t-test, Mann-Whitney U test and analysis of variance (ANOVA). Results:Both database and 9 paired clinical tissue sample results demonstrate that STEAP3-AS1 expression was significantly downregulated in BC compared with normal breast tissues (P < 0.05). Compared with the estrogen receptor/progesterone receptor (ERPR)-negative (-)/human epidermal growth factor receptor-2 (Her2)-positive (+) subtype, the ERPR(+)/Her2(-) and ERPR(-)/Her2(-) subtypes exhibited a significantly lower expression level of STEAP3-AS1 (P < 0.05). Overexpression of STEAP3-AS1 markedly suppressed the proliferation, migration, and invasion capabilities of MDA-MB-231 and MCF-7 cells compared with negative controls (P < 0.05). Furthermore, STEAP3-AS1 exhibited a positive synergistic effect with its sense strand STEAP3, inhibiting BC cell migration and invasion. Conclusions:This study is the first to demonstrate the tumor-suppressive role of STEAP3-AS1 in BC. These findings provide novel insights into the mechanisms underlying BC progression and offer critical theoretical support for the development of new therapeutic strategies.
Purpose The present study sought to evaluate whether the prognosis for young patients diagnosed with breast cancer improved over the past two decades (2001–2020). Methods The data were obtained from the Surveillance, Epidemiology, and End Results (SEER) database. Patients were grouped by year of diagnosis (Group1: 2001–2005, Group2: 2006–2010, Group3: 2011–2015, Group4: 2016–2020). A Kaplan-Meier curve showed the trend of suvival. The log-rank tests were used to statistically analyse the prognosis of variables. Hazard ratios and 95% confidence intervals were estimated by univariate and multivariate analyses using Cox proportional hazards regression. Patients were stratified by key variables, and Kaplan-Meier survival curves were generated for each group. The log-rank test was then applied to evaluate the statistical significance of any observed differences in survival rates across these strata. Results In the multivariate Cox analysis, the following factors were identified as independent influencing factors of prognosis in young females with breast cancer: diagnosis year group, race, grade, stage, TNM stage, estrogen receptor (ER) status, progesterone receptor (PR) status, HER2 status, surgery, radiation therapy, chemotherapy (all P < 0.001). The survival analysis across the four groups was also statistically significant. The year of diagnosis was a significant prognostic factor, with the highest survival rate observed in the 2015–2020 group. Conclusions Our findings showed that the prognosis for young patients with early-stage breast cancer diagnosed between 2015 and 2020 was significantly better than for those diagnosed between 2001 and 2005.
Virtual cell is an emerging technology that integrates multiple disciplines, including biology, computer science, and artificial intelligence, to simulate cellular structures and functions. Compared with traditional methods, virtual cell technology offers a more holistic approach, enabling efficient simulation of cellular dynamics and prediction of biological phenomena. This technology holds significant potential in fields such as precision medicine, drug discovery, and synthetic biology. The development of virtual cells is driven by advancements in single-cell sequencing, subcellular imaging, and computational power, with platforms such as environment for cell simulation (E-Cell) and cell packing (CellPACK) enabling simulations across multiple biological scales. However, challenges remain, including data integration, model interpretability, and computational costs. Despite these challenges, virtual cell technology has made advances in drug development, disease research, and synthetic biology, offering a promising tool for personalized medicine and improving research accuracy. In the future, virtual cell technology is expected to find broader applications in cross-species simulations, quantum computing, and interdisciplinary collaborations.
BACKGROUND:Cancer-related fatigue (CRF) is a common and debilitating issue for patients with breast cancer, significantly impacting quality of life and treatment efficacy. Despite the proliferation of multidisciplinary research, a comprehensive quantitative synthesis is still lacking. Such a synthesis would delineate global research trends, collaborative networks, and thematic evolution in this field. A comprehensive bibliometric analysis is therefore needed to map the scientific landscape, identify knowledge gaps, and inform future research directions. METHODS:To map the scientific landscape of cancer-related fatigue in breast cancer, this study extracted relevant publications from the Web of Science Core Collection (WOSCC) spanning from 2000 to 2024. The subsequent bibliometric analysis was conducted using specialized tools including VOSviewer, CiteSpace, and the R package "Bibliometrix" to meticulously chart the evolving trends and collaborative networks within this field. RESULTS:This study analyzed 4,549 documents from 56 countries, among which the United States leads in terms of scientific research output. Since 2015, the number of annual papers on CRF in breast cancer has continued to increase. The University of Texas MD Anderson Cancer Center was the most productive institution, and Supportive Care in Cancer published the highest number of related articles. The Journal of Clinical Oncology received the highest citation count. Christine Miaskowski was the most prolific author, and Julienne E. Bower was the most frequently co-cited researcher. Emerging research hotspots include keywords such as "patient-reported outcome measures", "quality of life"and "cancer-related fatigue". CONCLUSION:This study offers a foundational resource for scholars investigating the evolving landscape of breast cancer-related fatigue research, underscoring 'quality of life' and 'intervention' as critical priorities and pivotal directions for future inquiry.
CDK4/6 inhibitors combined with endocrine therapy (ET) are widely used in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 −) breast cancer (BC). Dermatologic adverse events (AEs) are increasingly recognized, but their overall risk across randomized trials remains unclear. This systematic review and meta-analysis was conducted in accordance with PRISMA 2020 and registered in PROSPERO (CRD42024591531). PubMed, Embase, and CENTRAL were searched from inception to February 8, 2026 for phase II, III randomized controlled trials (RCTs) comparing CDK4/6 inhibitor–based regimens plus ET versus non-CDK4/6 control regimens. Risk ratios (RRs) with 95
BACKGROUND:The bidirectional relationship between autoimmune diseases and malignancy has been widely discussed. And the relationship between autoimmune diseases and the risk of malignancy varies. Here, we categorized and re-analyzed the evidence of the association between six autoimmune diseases and malignancy risk, in order to provide ideas for the prevention of malignancy in the long-term individualized management of patients with autoimmune diseases. METHODS:We systematically searched the relevant literatures in PubMed, Web of Science and Cochrane Library to identify and re-analyze studies methodically on the association between six autoimmune diseases and their malignancy risk. Our results showed that. RESULTS:We included 34 meta-analyses including systematic lupus erythematosus, rheumatoid arthritis, psoriasis, ankylosing spondylitis, primary Sjogren's syndrome, multiple sclerosis, totalling 742 studies. Our results showed that the remaining five AIDs, with the exception of MS, were positively associated with the risk of overall malignancy. Among them, patients with SLE had the highest risk of developing lymphomas, oropharyngeal cancer and non-Hodgkin's lymphoma, and the lowest risk of developing uterine cancer, melanoma and endometrial cancer. The RA patients had the highest risk of developing lymphomas, Hodgkin's lymphoma and non-Hodgkin's and the lowest risk of colon cancer. pSS patients had the highest risk of lymphoma. MS patients had the highest risk of lung cancer and the lowest risk of testicular cancer. AS patients had the highest risk of lymphoblastic leukemia. PsO patients had the highest risk of keratinocyte cancer. CONCLUSION:Patients with systematic lupus erythematosus, rheumatoid arthritis, psoriasis, ankylosing spondylitis and primary Sjogren's syndrome lead to an increased risk of overall malignancy, whereas patients with MS lead to a decreased risk of overall malignancy. However, the risk relationship between the same AIDs and different malignancies varied.
This study aimed to establish and validate a machine learning model for predicting moderate-to-severe cancer-related fatigue (CRF) 2 years after completion of anti-tumor therapy in breast cancer patients. Clinical and laboratory data from 183 patients were retrospectively collected. Candidate predictors were screened using multivariate logistic regression, and seven algorithms—logistic regression, decision tree, random forest, support vector machine, extreme gradient boosting (XGBoost), k-nearest neighbor, and naïve Bayes—were constructed in the training cohort and validated in the testing cohort. Model performance was assessed by discrimination, calibration, and decision curve analysis. The 2-year incidence of moderate-to-severe CRF was 54.0
Adding immunotherapy to chemotherapy can modestly improve the pathological complete response (pCR) rate in triple-negative breast cancer (TNBC), while our previous NeoSAC study demonstrated that combining anti-angiogenic therapy can further enhance pCR. However, research on the mechanisms underlying the efficacy differences and biomarker comparisons across these treatment regimens remains insufficient. Female TNBC patients were consecutively enrolled into three groups: chemotherapy (chemo), chemo-immunotherapy (chemo-ICI), and chemo-immunotherapy-anti-angiogenesis (chemo-ICI-AA, from our NeoSAC study, NCT04722718). Efficacy and safety were compared, with RNA sequencing and immune microenvironment analyses conducted to explore mechanisms of efficacy differences and identify potential biomarkers. The total pCR rates in the chemo, chemo-ICI, and chemo-ICI-AA groups were 43.3
The occurrence and progression of breast cancer (BCa) are complex processes involving multiple factors and multiple steps. The tumor microenvironment (TME) plays an important role in this process, but the functions of immune components and stromal components in the TME require further elucidation. In this study, we obtained the RNA-seq data of 1086 patients from The Cancer Genome Atlas (TCGA) database. We calculated the proportions of tumor-infiltrating immune cells (TICs) and immune and stromal components using the CIBERSORT and ESTIMATE methods, and we screened differentially expressed genes (DEGs). Univariate Cox regression analysis of overall survival was performed on the DEGs, and a protein–protein interaction network of their protein products was generated. Finally, the hub gene CD5 was obtained. High CD5 expression was found to be associated with longer survival than low expression. Gene set enrichment analysis showed that DEGs upregulated in the high-CD5 expression group were mainly enriched in tumor- and immune-related pathways, while those upregulated in the low-expression group were enriched in protein export and lipid synthesis. TIC analysis showed that CD5 expression was positively correlated with the infiltration of CD8+ T cells, activated memory CD4+ T cells, gamma delta T cells, and M1 macrophages and negatively correlated with the infiltration of M2 macrophages. CD5 can increase anticancer immune cell infiltration and reduce M2 macrophage infiltration. These results suggest that CD5 is likely a potential prognostic biomarker and therapeutic target, providing novel insights into the treatment and prognostic assessment of BCa.
Upper extremity lymphedema, a major complication post-breast cancer surgery, severely impacts quality of life. While body mass index (BMI) is suggested as a risk factor for postoperative breast cancer-related lymphedema (BCRL), evidence is inconsistent. This meta-analysis systematically evaluates BMI’s impact on postoperative lymphedema to resolve discrepancies and provide accurate insights. The authors conducted comprehensive literature searches from inception to October 7, 2024, in major English-language databases, including PubMed, Embase, and Cochrane. To assess the association between BMI and postoperative BCRL, odds ratio (OR) with 95
ABSTRACT Background While tumor cells can affect the biological behavior of malignant tumors, the tumor microenvironment (TME) also plays an important role in the occurrence, development, and metastasis of tumors. The dynamic changes in the immune and stromal components of the TME and their correlations with breast cancer (BCa) patient prognosis may help guide clinical practice. Methods In this study, transcriptomic data and clinical information of BCa samples were obtained from The Cancer Genome Atlas database. The immune score and matrix score were calculated using the ESTIMATE algorithm. Examining the differentially expressed genes (DEGs), protein–protein interaction network development, and univariate Cox analysis helped identify CD48 as a key BCa‐related gene. Results The DEG and survival analysis results showed that CD48 was significantly upregulated in BCa samples compared with normal samples, potentially affecting patient prognosis. Gene set enrichment analysis showed that high CD48 expression was mainly associated with immune‐related pathways, suggesting that CD48 may be an important factor for maintaining an immune‐dominant TME in BCa. Analysis of tumor‐infiltrating immune cell types showed that high expression of CD48 could inhibit the infiltration of M2 macrophages and promote the entry of CD8+ T cells, CD4+ T cells, and M1 macrophages into the TME to exert anti‐tumor effects. Conclusions CD48 may serve as an effective biomarker for predicting BCa patient prognosis and a potential immune‐related therapeutic target.
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.
Emerging nanodrug delivery strategies seek to overcome tumor heterogeneity and enhance drug penetration in the dense matrix of solid tumors. This study presents a dual-responsive nanoplatform, poly(lactic-co-glycolic acid)-disulfide-polyethylene glycol-glutamate (PLGA-SS-PEG-Glu) loaded with Gambogic acid (GA), engineered to exploit γ-glutamyltranspeptidase (GGT) and glutathione (GSH) triggers specific to the triple-negative breast cancer (TNBC) microenvironment. Designed with Boc-L-Glutamic Acid-1-tert-butyl ester (Boc-Glu-OtBu), this nanoplatform achieves enzyme-triggered charge reversal to enhance tumor penetration, facilitating GGT-induced charge-switching and GSH-responsive GA release. In vitro, PLGA-SS-PEG-Glu@GA shows potent cytotoxicity (IC50 = 0.80 μg/ml) against 4T1 TNBC cells, inducing apoptosis and inhibiting cell proliferation through energy-dependent, GGT-mediated endocytosis. Compensatory Nrf2/HO-1 activation mechanistically induced by GA-loaded nanoplatform ultimately potentiated mitochondrial apoptotic pathway (Bcl-2/caspase-3) initiation, promoting apoptosis. In vivo, this nanoplatform leveraged its tumor-specific enzymatic and redox microenvironment-responsive properties to achieve enhanced deep intratumoral penetration. Treatment for 2 weeks effectively suppressed primary tumor growth, while extended therapy to one month significantly inhibited the formation of pulmonary metastatic foci. This dual-responsive strategy not only elevates drug bioavailability at the tumor site but also provides a promising solution to overcome critical barriers in solid tumor drug delivery.
Chemotherapy-induced fatigue reduces not only the quality of life of patients but also effect their recurrence-free survival rate. Although electroacupuncture can relieve fatigue, it has limited affect on some patients. Therefore, appropriate biomarkers are needed to help screen patients who can benefit from electroacupuncture treatment of fatigue. We conducted this study to explore the predictive ability of SNPs on the efficacy of electroacupuncture in the treatment of fatigue in patients with breast cancer after adjuvant chemotherapy. Our study included breast cancer patients with fatigue after receiving paclitaxel and/or anthracycline based adjuvant chemotherapy. The patients were divided into the electroacupuncture group and the control group. The electroacupuncture treatment group received adjuvant chemotherapy and electroacupuncture treatment, while the control group only received adjuvant chemotherapy, and then compared the fatigue relief degree of two groups. In addition, we used NCBI dbSNP and PharmGKB databases to select fatigue related genes and their SNPs. We collected peripheral blood from the included patients for SNPs typing, and recorded the efficacy of electroacupuncture to analyzed the correlation between different SNPs and therapeutic efficacy. The side effects of electroacupuncture treatment were also recorded. 76 patients in the electroacupuncture group and 48 patients in the control group were enrolled. In the electroacupuncture group, 63 patients (82.9%) experienced moderate to severe fatigue (BFI score > 3). After electroacupuncture treatment, the number of patients with a BFI score of > 3 was 46 (60.5%). Therefore, the fatigue symptoms of 26.9% patients were significantly improved (P < 0.05). In the control group, which did not receive electroacupuncture treatment, 40 of 48 patients had a BFI score of > 3. Following the same observation time used in the electroacupuncture group, 36 patients had a BFI score of > 3 points. Thus, fatigue was not significantly relieved in the control group (83.3% vs. 75.0%, P > 0.05). We included 56 patients in our analysis of the correlation between SNPs and electroacupuncture treatment effects. We divided the patients into an effective group and ineffective group according to therapeutic effects. Our results indicated that the effective rate of electroacupuncture treatment with IL1A rs3783550 AC and CC genotypes was higher than that with other genotypes (AC: 84.6%, CC: 81.8%, AA: 33.0%, P < 0.05). Similarly, the effective rate of electroacupuncture treatment with HTR1A rs6295 GG and CC genotypes was higher than that with other genotypes (GG: 63.0%, CC: 55.6%, GC: 18.2%, P < 0.05). However, no other genotypes were related to the effect of electroacupuncture treatment on fatigue. Our result showed that electroacupuncture has therapeutic effect on fatigue after adjuvant chemotherapy for breast cancer and the side effects are tolerable. In addition, IL1A rs3763550 and HTR1A rss6295 can predict the therapeutic effect of electroacupuncture on fatigue after adjuvant chemotherapy in breast cancer, which helps to better screen patients who can benefit from electroacupuncture treatment.
The incidence of autoimmune diseases and breast cancer is significantly higher in women compared to men. Previous observational studies have not conclusively determined the relationship between these two conditions. This study utilizes the Mendelian randomization approach to investigate the genetic association between autoimmune diseases and breast cancer. Two-sample Mendelian randomization was conducted on a European population using the GWAS database. The inverse variance-weighted method served as the primary analytical approach. The MR-PRESSO test was applied to detect horizontal pleiotropy. To ensure result robustness, the FDR correction method was used. The study revealed that Sjögren’s syndrome lowers the overall risk of breast cancer (OR 0.96, 95
Background: Antibody-drug conjugates (ADCs), as a new type of targeted drug, have been widely used in breast cancer patients in recent years. However, while achieving better efficacy, its hepatotoxicity should not be ignored.Objectives: To clarify the incidence of hepatotoxicity associated with ADCs and compare the incidence of hepatotoxicity of ADCs with different drugs.Design: We performed a systematic review and meta-analysis to summarize the clinical trials and combined the data using meta-analysis.Methods: We searched the PubMed, Embase, and Web of Science databases up to March 12, 2023. The primary outcome was the incidence of ADC-related hepatotoxicity in breast cancer patients. The data were merged using Stata 17.0 software.Results: ADCs caused a high incidence of all grades of hepatotoxicity. Sacituzumab govitecan caused the highest incidence of all grades of alanine aminotransferase (ALT) elevation at 25.30% (95% confidence interval (CI): 19.29-31.82). Trastuzumab deruxtecan caused the highest incidence of all grades of aspartate aminotransferase (AST) elevation. The highest incidence of AST elevation was 31.89% (95% CI: 18.56-46.85). Conversely, trastuzumab emtansine caused the highest incidence of grade >= 3 AST and ALT elevation (incidence rates were 3.95% (95% CI: 2.39-5.85) and 3.42% (95% CI: 1.95-5.24), respectively).Conclusion: Hepatotoxicity is an adverse reaction that cannot be ignored when ADCs are used for treating breast cancer. Moreover, clinicians should pay more attention to the assessment of patients' liver function and monitoring of liver indices, particularly ALT and AST, when using ADCs.
Background CDK4/6 inhibitors is highly valued, but the incidence of cardiovascular events (CVAEs) associated with CDK4/6 inhibitors is not clear. Methods Eligible CVAEs were extracted from the [ClinicalTrials.gov][1] registry. A systematic search of electronic databases (PubMed, Embase, Cochrane Library, and important meetings) until 3 September 2023 was conducted. A disproportionality analysis was performed from the first quarter (Q1) of 2013 to Q1 of 2023 using data from the FDA Adverse Event Reporting System database. Study heterogeneitywas assessed using the I2 statistic. Using Peto OR and inverse variance methods to calculate the risk and incidence of CVAEs associated with CDK4/6 inhibitors. Findings 21 RCTs and cohort trials (n=24,331) were included. During the follow-up period of 8.4 to 34.0 months, CDK4/6 inhibitors significantly increased the risk of CVAEs (Peto OR, 1.64, 95% confidence interval, 1.23 - 2.21, P < 0.01). The rates of QT prolongation and deep vein thrombosis were 98.83 (89.6-100.1) and 6.41 (5.23-7.18) per 1000 patients, respectively. Moreover, we identified 11 CVAEs that were not reported in RCTs or cohort studies, acute coronary syndrome, atrial fibrillation, and mobile thrombophlebitis etc. were strongly correlated with CDK4/6 inhibitors. Furthermore, the risk of CVAEs varied depending on the specific CDK4/6 inhibitors used, its combination with different endocrine therapies, and the patient’s treatment stage. Interpretation CDK4/6 inhibitors increase the risk of CVAEs, some of which may lead to serious consequences, early recognition and management of CVAEs is of great importance in clinical practice. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was supported by two funding sources: 1. The National Natural Science Foundation of China (Grant Number: 82160859), and 2. The Kunlun Talents Program of Qinghai Province for high-end innovative and entrepreneurial talents. The funders had no role in the study design, nor in the collection, analysis, interpretation of data, writing of the report, or the decision to submit the article for publication. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: \---|- I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as [ClinicalTrials.gov][1]. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes YES [1]: http://ClinicalTrials.gov
PURPOSE We aim to determine the effectiveness of adding electroacupuncture to standard triple antiemetic therapy for treating chemotherapy-induced nausea and vomiting (CINV). METHODS From March 2022 to December 2023, a randomized, blind, sham-controlled trial conducted across six Chinese hospitals investigated patients with breast cancer undergoing highly emetogenic chemotherapy (HEC). Patients were randomly assigned to either true electroacupuncture (n = 120) or sham electroacupuncture (n = 119) groups, with both groups receiving standard triple antiemetic therapy. The primary end point was the proportion of complete protection (no vomiting, no need for rescue treatment, and no significant nausea, as evaluated using the visual analog scale [VAS]) within 120 hours after receiving HEC. RESULTS Among 239 randomly assigned patients, 235 (98.3%) completed the trial. In the full analysis set, compared with the sham electroacupuncture group, the true electroacupuncture group demonstrated a significant increase in the complete protection rate from 34.5% to 52.9% ( P = .004). Additionally, true electroacupuncture also showed enhanced total control (4.3% v 13.4%; P = .014), no significant nausea (37.9% v 58.8%; P = .001), no nausea (4.3% v 13.4%; P = .014), and nausea VAS score = 0 mm (4.3% v 12.6%; P = .023). However, the occurrence of no vomiting in the overall stage was similar (76.7% v 73.9%; P = .622) in both groups. Post hoc exploratory analysis showed a significantly higher rate of complete protection during the delayed stage in the true electroacupuncture group compared with the sham electroacupuncture group, with no significant difference observed during the acute stage. CONCLUSION Adding true electroacupuncture to standard triple antiemetic therapy significantly enhances the efficacy of CINV treatment in patients with breast cancer receiving HEC.