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Tongue coating has been used as an effective signature of health in traditional Chinese medicine (TCM). The level of greasy coating closely relates to the strength of dampness or pathogenic qi in TCM theory. Previous empirical studies and our systematic review have shown the relation between greasy coating and various diseases, including gastroenteropathy, coronary heart disease, and coronavirus disease 2019 (COVID-19). However, the objective and intelligent greasy coating and related diseases recognition methods are still lacking. The construction of the artificial intelligent tongue recognition models may provide important syndrome diagnosis and efficacy evaluation methods, and contribute to the understanding of ethnopharmacological mechanisms based on TCM theory.The present study aimed to develop an artificial intelligent model for greasy tongue coating recognition and explore its application in COVID-19.Herein, we developed greasy tongue coating recognition networks (GreasyCoatNet) using convolutional neural network technique and a relatively large (N = 1486) set of tongue images from standard devices. Tests were performed using both cross-validation procedures and a new dataset (N = 50) captured by common cameras. Besides, the accuracy and time efficiency comparisons between the GreasyCoatNet and doctors were also conducted. Finally, the model was transferred to recognize the greasy coating level of COVID-19.The overall accuracy in 3-level greasy coating classification with cross-validation was 88.8% and accuracy on new dataset was 82.0%, indicating that GreasyCoatNet can obtain robust greasy coating estimates from diverse datasets. In addition, we conducted user study to confirm that our GreasyCoatNet outperforms TCM practitioners, yet only consuming roughly 1% of doctors' examination time. Critically, we demonstrated that GreasyCoatNet, along with transfer learning, can construct more proper classifier of COVID-19, compared to directly training classifier on patient versus control datasets. We, therefore, derived a disease-specific deep learning network by finetuning the generic GreasyCoatNet.Our framework may provide an important research paradigm for differentiating tongue characteristics, diagnosing TCM syndrome, tracking disease progression, and evaluating intervention efficacy, exhibiting its unique potential in clinical applications.

Treatment of malignant tumors encompasses multidisciplinary comprehensive diagnosis and treatment and reasonable combination and arrangement of multidisciplinary treatment, which is not a simple superimposition of multiple treatment methods, but a comprehensive consideration of the characteristics and specific conditions of the patients and the tumor. The mechanism of tumor elimination by restoring the body’s immune ability is consistent with the concept of “nourishing positive accumulation and eliminating cancer by itself” in traditional Chinese medicine (TCM). The formation and dynamic changes in the tumor microenvironment (TME) involve many different types of cells and multiple signaling pathways. Those changes are similar to the multitarget and bidirectional regulation of immunity by TCM. Discussing the relationship and mutual influence of TCM and antitumor therapy on the TME is a current research hotspot. TCM has been applied in the treatment of more than 70% of cancer patients in China. Data have shown that TCM can significantly enhance the sensitivity to chemotherapeutic drugs, enhance tumor-suppressing effects, and significantly improve cancer-related fatigue, bone marrow suppression, and other adverse reactions. TCM treatments include the application of Chinese medicine monomers, extracts, classic traditional compound prescriptions, listed compound drugs, self-made compound prescriptions, as well as acupuncture and moxibustion. Studies have shown that the TCM functional mechanism related to the positive regulation of cytotoxic T cells, natural killer cells, dendritic cells, and interleukin-12, while negatively regulating of regulatory T cells, tumor-associated macrophages, myeloid-derived suppressive cells, PD-1/PD-L1, and other immune regulatory factors. However, the application of TCM in cancer therapy needs further study and confirmation. This article summarizes the existing research on the molecular mechanism of TCM regulation of the TME and provides a theoretical basis for further screening of the predominant population. Moreover, it predicts the effects of the combination of TCM and antitumor therapy and proposes further developments in clinical practice to optimize the combined strategy.

Background Diarrhea is a common adverse reaction in patients with cancer receiving chemotherapy, for which there is currently no effective method of treatment. Shengjiang Xiexin decoction (SXD), a classic traditional Chinese medicine (TCM) formula, has shown efficacy in alleviating irinotecan-induced diarrhea in preliminary clinical studies. The current study is designed to assess the efficacy and safety of SXD for prophylaxis against irinotecan-induced diarrhea. Additionally, we employ a new approach to analyze and evaluate the data based on the patients’ uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype, which predicts the risk of diarrhea. Methods and design A prospective, double-blind, randomized, placebo-controlled trial will be conducted in patients with small cell lung cancer (SCLC) from five hospitals in China. For this study, 100 irinotecan-naïve patients will be randomly allocated to either the SXD or placebo arms in a 1:1 ratio. Stratified randomization will be used to divide subjects by UGT1A1 genotype into groups with differing risk of diarrhea. The trial will consist of two cycles of chemotherapy with 14 days of oral administration of SXD or placebo administered beginning between 3 days before and up to 11 days after initiation of each chemotherapy cycle. The primary study outcome is the incidence of diarrhea. Secondary outcomes include the degree of diarrhea, the degree of neutropenia, the rate of alterations in chemotherapy regimens, the amount of antidiarrheal drug taken, the rate of hospitalization, and evaluation of chemotherapy efficacy. Discussion This study is the first to use the UGT1A1 genotype to stratify patients into groups based on their risk of diarrhea, and to provide a complete assessment of chemotherapy-related diarrhea (CRD), including records of diarrhea duration, grading the severity of diarrhea, and evaluating concomitant symptoms. Study results will provide high-level clinical evidence on the use of SXD as prophylaxis for CRD. Trial registration Chinese Clinical Trial Register: ChiCTR1800018490. Registered on 20 September 2018. Retrospectively registered. http://www.chictr.org.cn/edit.aspx?pid=25250&htm=4c

Additional files 1. Standard protocol items: recommendation for interventional trials (SPIRIT) 2013 checklist: recommended items to address in a clinical trial protocol and related documents.

Supplemental material, supplement-EDITS for Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, and Parallel-Controlled Trial by Ran Yu, Xuefeng Wu, Liqun Jia and Yanni Lou in Integrative Cancer Therapies

Introduction Inflammation, ulcer, reflux, polyp, and metaplasia or dysplasia of the upper gastrointestinal tract are frequently encountered non-malignant upper gastrointestinal disorders (NUGDs) in clinical practice. Abnormal tongue features (ATFs) are a series of morphological changes occurring on the dorsal surface of the tongue according to traditional Chinese medicine theory. Red tongue, purple tongue, yellowish, greasy tongue, fissured tongue, teeth-printed tongue, ecchymotic tongue, peeled or geographically coated tongue are the most frequently encountered ATFs and show a close relationship to chronic diseases. This study was to investigate the prevalence of ATFs in NUGDs and to explore the potential correlation between them. Methods This was a cross-sectional study conducted at China–Japan Friendship Hospital, China. Patients aged over 18 years old and met the standards set for upper gastrointestinal endoscopy in the endoscopic center were included. The tongue images of all the participants were captured using a smart phone. The seven ATFs were determined using a manual-interpretation-based, computer-aided tongue diagnosis method by three TCM practitioners.The participants were then categorized into different NUGDs according to endoscopic findings and pathological examinations. Chi-square test was performed to analyze the distribution differences of ATFs by gender and age. Univariate and multivariate logistic regression analyses were used to determine the relationship between ATFs and NUGDs. Results Among disease manifestations, inflammation (98.2%) and gastroesophageal reflux disease (62.4%) were highly prevalent, whereas fissured tongue (34.3%) was the most common ATF. The prevalence of ATFs was significantly influenced by gender and age. Fissured tongue, red tongue, and yellowish, greasy tongue (all P Conclusion Fissured tongue was found to be related to the UGPLs. Since the participants of this study were from a hospital-based population, a multi-center, community-based study is warranted to confirm these results in the future.

Background Hand-foot syndrome (HFS) is an adverse effect which triggered by chemotherapy, Capecitabine has the highest reported HFS incidence at about 50% to 60%. LC09 is composed of Chinese herbs and is used to soak hands and feet. Former clinical study and animal experiment have shown that Chinese herbal compound LC09 can alleviate numb, pain and inflammation. This study is aimed to evaluate its validity via strictly randomized, double-blind, placebo-controlled trial. Methods 156 patients which is diagnosed as HFS randomly assigned 1:1 to treatment group (n = 78) and control group (n = 78) in 4 centers. Intervention of LC09 or placebo is lasting for 6 weeks and evaluated every week by NCI degree, NRS pain scores. Assess quality of life using DLQI (dermatology life quality index) scale and IADL (instrumental activity of daily living) scale at the beginning one week later and the end. Results NCI degree and NRS pain scores between two groups are significant difference (p Conclusions Chinese herbal compound LC09 can decrease NCI degree and alleviate pain significantly. Besides, it can also increase chemical completion rate. But effect for quality of life still needs to search with more specific scale. Legal entity responsible for the study The authors. Funding Ministry of Science and Technology of the People’s Republic of China (2015BAI04B07). Disclosure All authors have declared no conflicts of interest.

Objective: The study objective was to determine the reliability and validity of the Chinese version of the Functional Assessment of Chronic Illness Therapy – Ascites Index (FACIT-AI). Methods: A forward-backward translation procedure was adopted to develop the Chinese version of the FACIT-AI, which was tested in 69 patients with malignant ascites. Cronbach's α, split-half reliability, and test-retest reliability were used to assess the reliability of the scale. The content validity index was used to assess the content validity, while factor analysis was used for construct validity and correlation analysis was used for criterion validity. Results: The Cronbach's α was 0.772 for the total scale, and the split-half reliability was 0.693. The test-retest correlation was 0.972. The content validity index for the scale was 0.8–1.0. Four factors were extracted by factor analysis, and these contributed 63.51% of the total variance. Item-total correlations ranged from 0.591 to 0.897, and these were correlated with visual analog scale scores (correlation coefficient, 0.889; P

e21590 Background: Lung cancer remains the leading cause of cancer-related death in China. DCVAC/LuCa is an active autologous cellular immunotherapy consisting of autologous DCs loaded with NSCLC antigens from NSCLC cell lines. SQFZ is a kind of TCM injection commonly uesed for NSCLC, made from Ginseng and Astragalus membranaceus. Intent of this study is to evaluate the efficacy and safety of DCVAC/LuCa plus chemotherapy and TCM in patients with advanced NSCLC and wild type driving gene(EGFR/ALK). Methods: This study consist of screening/leukapheresis/treatment/follow-up period. On the treatment period, chemotherapy started after leukapheresis. Four cycles are recommended with limitation to maximum 6 cycles. Up to 12 subcutaneous doses of DCVAC/LuCa treatment were administrated on the 15th day of chemotherapy cycle every 3 weeks for 4 doses, and continued alone after chemotherapy finishes/stops every 6 weeks for the remaining 8 doses. TCM therapies were administered on the -3 to 3 days of DCVAC/LuCa. After completion of the total 12 doses DCVAC/LuCa or discontinuation of study treatment, patients will be followed up until experienced OS event or till 1 year of survival time. The primary efficacy endpoint included ORR, PFS and survival. Results: 23 pts were included, 19 males and 4 females, median age 63(48-80). Pathological type:16 adenocarcinoma, 5 squamous cell carcinoma and 1 other. 7 Ⅲb and 16 Ⅳ stage. ORR was 17.39%(4/23), DCR was 60.87%(14/23). Median PFS was 10.9 months, median follow-up in surviving patients was 22.3 months, 1-year survival is currently 92.86%, 18-months survival is currently 79.59%. 1 case was diagnosed as acute myelogenous leukemia myelodysplastic syndrome after 9 doses of DCVAC/LuCa. There were no other adverse events related to DCVAC/LuCa treatment TCM therapies in this study. Conclusions: DCVAC/LuCa, combined with standard chemotherapy and TCM had exhibited the potential to improve the survival in patients with advanced NSCLC, and decrease the occurrence of adverse events. But the sample size of this study is small, a further clinical investigation is needed.

Background Molecular targeted anticancer drugs such as multikinase inhibitors have shown obvious therapeutic advantages in a variety of tumors. The occurrence of hand-foot skin reaction (HFSR) is positively correlated with therapeutic effect, but it is also the most common cause of dose limiting toxicity for this treatment. This can lead to interruption or decrement of the treatment, a reduction in quality of life for patients, as well as potentially leading to secondary infections. As a result, the curative effect of targeted anticancer drugs will be negatively impacted. Currently, there is no certain and effective therapy. External use of Chinese herb medicine LC09 in the early treatment of HFSR has shown positive outcomes, but it is necessary to carry out further clinical research to confirm. Objectives The purpose of this study was to investigate the efficacy and safety of topical soaks of Chinese herbal medicine LC09 for HFSR induced by molecular targeted anticancer drugs. Methods The trial is a prospective, randomized, controlled, double-blind, monocentric, and interventional study. A total of 66 patients with HFSR will be recruited and randomly assigned to receive either LC09 Granules or placebo. The primary outcomes are the assessment of HFSR grade and pain score. The secondary outcomes are the evaluation of the quality of life, incidence of targeted drug dosage reduction, and incidence of targeted drug withdrawal. Discussion This prospective, randomized clinical trial will provide valuable data regarding the efficacy and safety of topical soak treatments with LC09 granules for HFSR. Positive results would provide evidence-based complementary therapeutic approach future treatments of HFSR. Trial registration Chinese Clinical Trial Registry, http://www.chictr.org.cn, ChiCTR1900023679. Registered on 7 June 2019.

Objective To compare the efficacy of integrated Chinese and Western Medicine with that of only Western Medicine for the treatment of malignant ascites. Methods All randomized controlled trials (January 2004 to March 2013) from the China National Knowledge Infrastructure Database, Chinese Biomedical Literature Database, and Wanfang Database were searched with keywords. Meta-analysis was conducted by combining the odds ratios of the individual studies. Review Manager 5.0 was used for the analysis. Results One thousand one hundred and fifty-six patients from 19 randomized controlled trails were included. Of them, 630 patients were treated with integrated Chinese and Western Medicine (the integrative group), and 526 patients were treated with Western Medicine alone (the control group). The Meta-analysis showed that the total effective rate was 78.73% in the integrated group, and 59.13% in the control group. The effective percentage was significantly higher in the integrative group than that of the control group [ OR = 2.85, 95% CI (2.16, 3.74), P Conclusion The short-term curative effect in the integrative group was better than that in the control group. Integrative medicine may be beneficial for malignant ascites.

Cases of chemotherapy-induced pancreatitis are rarely reported and among those diagnosed, the majority are mild and self-limiting. However, no previous cases of fulminant acute pancreatitis (FAP) induced by chemotherapeutic agents have been reported. The current study presents a case of FAP in a 62-year-old female on gemcitabine and capecitabine therapy. The patient was admitted to the China-Japan Friendship Hospital (Beijing, China) with the symptoms of acute pancreatitis two days after the completion of the first cycle of chemotherapy. Shock, hypoxemia and acute renal failure supervened, which resulted in mortality. As the common etiologies of pancreatitis were eliminated, a correlation between the incidence of FAP, and pancreatic cancer or chemotherapy, or both was suspected. Clinicians should be aware of this potential adverse effect when prescribing chemotherapeutic agents, particularly in patients with pre-existing risk factors for pancreatitis.

e12006 Background: Capecitabine(Cape) maintenance therapy after response to Cape-based combination chemotherapy(chemo) is one of the standard regimens recommended by NCCN for metastatic breast canc...

e13560 Background: Hand-foot syndrome (HFS) is a common adverse reaction in clinical oncotherapy. HFS is mostly recorded in clinical observations or case reports, animal experiments are limited. Ph...

Background Chemotherapy-induced peripheral neuropathy (CIPN) can impact quality of life (QoL) and may lead to dose modification or treatment interruption, even when the therapy may prove beneficial. LC07 is an external compound Chinese herbal extract including Herba Geranii. Preclinical study showed that LC07 could relieve neuropathy pain and reduce pain neurotransmitter release in rats. The mechanism may be connected with Nerve growth factor level promoting and Intraepidermal nerve fiber regeneration. The trial was designed to evaluate the efficacy and safety of LC07, versus placebo for CIPN caused by oxaliplatin. Methods Eligible patients (pts) with CIPN grade ≥ 1 (NCI-CTCAE v3.0) after oxaliplatin therapy. Pts were randomly assigned 2:1 to receive LC07 (Arm 1) versus placebo (Arm 2). Pts soaked their hands and feet in LC07 or placebo lotion for 20 minutes, twice daily for 7 days. Physical examination, NCI grade of CIPN, NRS scale of pain and Impact of pain measurement (NCCN Guidelines for Adult Cancer Pain) were assessed at baseline, and at 1 week. Pts also completed a daily diary to document symptoms, side effects and medication compliance. Evaluation criteria, CR as symptoms disappear completely, PR as NCI Grade decreases more than 1 level, PD as symptoms or Grade increased, Total response rate as CR + PR. Results 102 pts from 3 centers were enrolled. Arms were well balanced. Median age [range] was 58 [37-80], male/female was 62/40. NCI Grade was 1/2/3, 15/27/26 in Arm 1, 4/16/14 in Arm 2. In Arm 1/Arm 2, Total response rate was 75.36%/33.33%, CR 21.74%/3.03%, PR 53.62%/30.30%, PD 24.64%/66.67%. The mean score of Impact of pain measurement (QoL) before and after treatment were 24.22 ± 13.36 and 11.59 ± 13.40 in Arm 1, 25.74 ± 15.10 and 25.44 ± 16.79 in Arm 2 (out of a total of 70, p Conclusions Compound external Chinese herbal extract LC07 can treat CIPN, which is especially effective for relieving pain, can improve QoL of pts, easy use and safe. Thus may be helpful to continue beneficial anticancer therapy. Disclosure All authors have declared no conflicts of interest.

9049 Background: Hand-foot syndrome (HFS) and hand-foot skin reaction (HFSR) induced by anticancer therapy can impact quality of life (QoL) and may lead to dose modification or treatment interrupti...

1088 Background: With the capecitabine being increasingly used in the treatment of metastatic breast cancer (MBC), the common side effect of capecitabine, hand-foot syndrome (HFS) has become a main problem which can distress both physicians and patients. Severe HFS such as severe pain can have a negative impact on quality of life (QOL) of these patients and cause reduced dosage or even stopping chemotherapy. No effective treatment for HFS can be available at present. Over the years we have used LC07, a kind of external agents from Chinese herbs (Herba Geranii, etc.), to treat capecitabine-induced HFS. In this study, the efficacy and safety of LC07 were evaluated in patients with MBC and HSF. Methods: Eligible patients includes patients with MBC, who had HFS (NCI-CTC grade ≥1) after receiving single capecitabine chemotherapy (1,250 mg/m2, PO, twice daily, cycled days 1–14, every 21 days). LC07 granules 10g was dissolved in 1,000mL of warm water (keep 34°C-37°C in a footbath), the patients soaked their feet and hands in this lotion for 20 minutes, twice daily for 7 days. An independent researcher assessed symptoms before and after treatment. Evaluation criteria, CR as symptom disappearing completely, PR as NCI-CTC grade for HFS decreasing by more than 1 level after treatment, the total response rate as CR+PR. The QOL of these patients were also evaluated before and after treatment using a FACT-B questionnaire (Version 4.0-Chinese). Results: 42 patients (pts) have been enrolled in this study. All of them are Asian and female. Media age 51.5 yrs (25–72). Grade 1 for HFS was seen in 8 pts, G2 in 19 pts, and G3 in 15 pts. The total response rate was 83.3% (35/42), CR 38.1% (16/42), PR 45.2% (19/42). The average time from therapy to pain relief was 1.8±0.8 days, the skin lesion of HFS including dermatitis, peeling, ulceration have been improved after treatment. The QOL scores before and after treatment were 77.24±25.69 and 109.17±20.53, respectively (p < 0.01). No side effects such as skin allergies related to LC07 was found in this study. Conclusions: In the treatment of capecitabine-induced HFS, the external Chinese medicine LC07 is fast effective for relieving pain, and it has the features of easy use and no skin allergies. Thus LC07 can improve the QOL of patients with MBC and HFS. No significant financial relationships to disclose.