Background Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need. Objective The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. Methods A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests. Results Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group. Conclusions Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy. Trial Registration This trial is registered with ClinicalTrials.gov NCT02468141.
IntroductionCancer is a major health problem worldwide and the leading cause of death in many countries. The number of patients with cancer and socioeconomic costs of cancer continues to increase. SH003 is a novel herbal medicine consisting of Astragalus membranaceus, Angelica gigas and Trichosanthes Kirilowii Maximowicz. Preclinical studies have shown that SH003 has therapeutic anticancer effects. The aim of this study is to determine the maximum tolerated dose of SH003 in patients with solid cancers.Methods and analysisThis study is an open-label, dose-escalation trial evaluating the safety and tolerability of SH003. The traditional 3+3 dose-escalation design will be implemented. Patients with solid cancers will be recruited. According to dose level, the patients will receive one to four tablets of SH003, three times a day for 3 weeks. Toxicity will be evaluated using common terminology criteria for adverse events (CTCAE). Dose-limiting toxicities are defined as grade 3 or higher adverse events based on CTCAE. The maximum tolerated dose will be determined by the highest dose at which no more than one of six patients experiences dose-limiting toxicity.Ethics and disseminationThis study has been approved by the institutional review board of the Ajou University Hospital (reference AJIRB-MED-CT1-16-311). The results of this study will be disseminated through a scientific journal and a conference.Trial registration numberNCT03081819; Pre-results.
IntroductionCancer-related fatigue is a frequent symptom in patients with cancer and one of the most distressing symptoms in patients with breast cancer. Sipjeondaebo-tang (Juzen-taiho-to in Japanese or Shi-Quan-Da-Bu-Tang in Chinese) is a widely used herbal medicine for the treatment of fatigue in Korea, China and Japan. The purpose of the present study is to evaluate the feasibility of Sipjeondaebo-tang for cancer-related fatigue.Methods and analysisThe present study is a randomised, double-blind, placebo-controlled, cross-over study. Forty-eight patients with breast cancer who are indicated for doxorubicin and cyclophosphamide will be recruited. The participants will receive 3 g of Sipjeondaebo-tang or a placebo three times a day for 56 days. The primary outcome measurement is the change in the Brief Fatigue Inventory scores. The secondary outcome measurements include the changes in the Visual Analogue Scale (VAS) of fatigue, and quality of life measured by the European Organization for Research and Treatment of Cancer—QLQ-C30 and QLQ-BR23. VAS of fatigue will be measured on every visit, and other outcomes will be measured on visits 2, 4, 6 and 7. The total study period is 14 weeks.Ethics and disseminationThis study has been approved by the Institutional Review Board of the Catholic Kwandong University International St Mary’s Hospital (reference IS16MNSI0011). The results of this study will be published in a peer-reviewed journal and presented at a scientific conference.Trial registration numberNCT02858856; Pre-results.
Background:Cough is a common symptom that occurs in 25% of patients after lung cancer surgery. It might last a long time and degrade the quality of life of patients. Maekmoondong-tang (Bakumondo-to in Japanese or Mai-Men-Dong-Tang in Chinese) is a herbal medicine which has been widely used for respiratory diseases with cough in Korea, China, and Japan.Aims:The aim of the present study is to evaluate the efficacy and safety of Maekmoondong-tang for postoperative cough in patient with lung cancer.Methods/Design:This study is a randomized, double-blind, placebo-controlled, multicenter trial of Maekmoondong-tang. A total of 96 participants will be enrolled and allocated to 2 parallel groups: the Maekmoondong-tang group and the placebo group from 5 university hospitals. The participants will be administered either Maekmoondong-tang or a placebo 3 times a day for 4 weeks. The primary outcome measurement is the change in the Leicester Cough Questionnaire (LCQ) score. The secondary outcome measurements are the changes in the cough visual analog scale and Yin Deficiency Scale. The participants will visit 4 times in total for 4 weeks of trial period.Discussion:The present study will be the first multicener study to evaluate the efficacy and safety of Maekmoondong-tang for postoperative cough in patient with lung cancer surgery. The results of this study will provide a new treatment for cough using herbal medicine and will be a reference for planning clinical trial of herbal medicine in patient with cough.
Taeumjowi-tang (TJ001) is a traditional Korean medicine that usually prescribed for Tae-um person to regulate stomach-related symptoms including headache, indigestion, and jaundice. Other studies on anti-obesity effect of TJ001 have also been researched, but have never been reported as a cure for cancer. In the present study, we investigated the molecular mechanism that TJ001 induces G2/M cell cycle arrest in DU145 (p53-mutant) prostate cancer cells. The missense mutation in human p53 gene (TP53) confers oncological effect to tumor suppressor p53-mutant protein. In prostate cancer, this gain-of-function of p53-mutant is associated with androgen-independence, increased angiogenesis, and metastasis. Our in vitro studies showed that a water extract of TJ001 induced G2/M cell cycle arrest via p53-mutant status and p21WAF/CIP1 up-regulation. Conventinally, p21WAF/CIP1 is induced by mediating p53 regulation, but, in experiments, handling the p53-dependent and -independent pathway. Although serine15-phosphorylated p53 and p53 proteins remained unchanged, p21WAF/CIP1 expression is induced and cyclin B1/Cdc2 complex is inactivated by a decrease of cyclin B1. In addition, in p53-independent pathway, the level of Cdc25C expression decreased and Serine-216 phosphorylated Cdc25C increased. Generally, concomitant with G2/M cell cycle arrest come the apoptosis cell death, but in the study, prolonged G2/M cell cycle arrest developed not apoptosis but cell senescence. Therefore, our data suggest that TJ001 is helpful for p53-mutant prostate cancer treatment. Citation Format: Soo-Yeon Kang, Hyo In Kim, Se Hyang Hong, Jin Mo Ku, Kangwook Lee, Myeong-Sun Kim, Yu-jeong Choi, Chunhoo Cheon, Youme Ko, Ching Wen Huang, Yui Sasaki, Sohyeon Kang, Hye-Sook Seo, Tai Young Kim, Ji Hye Kim, Yong Cheol Shin, Seong-Gyu Ko. Taeumjowi-tang (TJ001) induces G2/M cell cycle arrest but not apoptosis in p53-mutant prostate cancer via up-regulation of p21WAF/CIP1 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 300. doi:10.1158/1538-7445.AM2017-300
Objective: We examined whether cucurbitacin D affects doxorubicin resistance of MCF7/ADR breast cancer cells. Methods: Cell viability was measured by MTT assay. Levels of p-STAT3, p-NF-κB, IκB, and caspases were measured by western blot analysis. Nuclear staining of Stat3 and NF-κB was measured by immunocytochemistry. STAT3 and NF-κB transcriptional activity was detected by STAT3 and NF-κB luciferase reporter gene assays. Analysis of cell cycle arrest was performed by flow cytometry. Induction of apoptosis by cucurbitacin D was measured by annexin VFITC/PI assay. Results: More than 90% of MCF7/ADR cells lived upon treatment with doxorubicin for 24 h. However, upon treatment with cucurbitacin D, cell death was more than 60%. Co-administration of cucurbitacin D and doxorubicin induced apoptosis, G2/M cell cycle arrest, and inhibited upregulated Stat3 by doxorubicin on MCF7/ADR cells. Additionally, cucurbitacin D led to an increase in the IκBα level in the cytosol and a decrease in the p-NF-κB level in the nucleus. Finally, cucurbitacin D inhibited translocation of Stat3 and NF-κB and decreased transcriptional activity in the nucleus. Conclusion: Cucurbitacin D decreases cell proliferation and induces apoptosis by inhibiting Stat3 and NF-κB signaling in doxorubicin-resistant breast cancer cells. Cucurbitacin D could be used as a useful compound to treat Adriamycin-resistant patients. Note: This abstract was not presented at the meeting. Citation Format: Jin Mo Ku, Se Hyang Hong, Myeong-Sun Kim, Hyo In Kim, Soo-Yeon Kang, Kangwook Lee, Yu-Jeong Choi, Chunhoo Cheon, CHING WEN HUANG, Youme Ko, Yui Sasaki, Sohyeon Kang, Ji Hye Kim, Hye Sook Seo, Tai Young Kim, Yong Cheol Shin, Seong-Gyu Ko. Cucurbitacin D induces cell cycle arrest and apoptosis by inhibiting STAT3 and NF-κB signaling in doxorubicin-resistant human breast carcinoma (MCF7/ADR) cells [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 2320. doi:10.1158/1538-7445.AM2017-2320
Background: Pharmacopuncture is a combination of acupuncture and herbal medicine, which involves the injection of herbal extracts into acupuncture points (acupoints). Pharmacopuncture has become one of the major therapeutic tools used in Korea; however, safety is one of the major concerns associated with it. We aim to systematically review clinical studies on the adverse events of pharmacopuncture in Korea. Methods: To collect data on the incidence and characteristics of adverse events (AEs) and to evaluate pharmacopuncture safety, 2 or more researchers will conduct a comprehensive search of pertinent English and Korean databases using the keywords “pharmacopuncture” and “adverse events.” Regardless of the participants’ conditions or treatment types, we will include clinical studies on the AEs of pharmacopuncture. Studies that were not conducted in Korea, and acupoint injections containing Western medications, vitamins, or autologous serum will be excluded from this study. The severity of AEs will be classified using the common terminology criteria for adverse events, and the causality between pharmacopuncture and AEs will be assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scale. The quality of identifying and reporting the AEs will be assessed using the McHarm scale. The risk of selection bias will be assessed using the Cochrane risk of bias and the risk of bias for non-randomized studies tools. Studies will be assessed for heterogeneity utilizing Higgins's I 2 statistics, and the risk of publication bias will be assessed and expressed in the form of a contour-enhanced funnel plot. Results and Conclusion: Comprehensive investigation of all types of clinical studies in Korea will provide clearer evidence of the safety of pharmacopuncture. The results of this study will be useful for traditional medical doctors and patients who use such treatments and interventions. Systematic Review Registration: Open Science Foundation (osf.io/umhyz).
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