International Center of TCM for Cancer An Example

International Center of TCM for Cancer: An Example of a Successful International Collaboration Lorenzo Cohen, Ph. D. Director, Integrative Medicine Program FUDAN UNIVERSITY SHANGHAI CANCER CENTER

International Center of Traditional Chinese Medicine for Cancer (国际中医肿瘤中心) Lorenzo Cohen, Ph. D. , Principal Investigator/Co-Director Luming Liu, M. D. , Co- Principal Investigator/Co-Director Zhiqiang Meng, M. D. , Ph. D. , Deputy Director n n n R 21 (CA 108084, NCI) U 19 (CA 12153031, NCI) 国家科技部基金 上海市科委和肿瘤医院 金蟾药业股份有限公司 (提供免费药物)

International Center of Integrative Oncology (ICIO)

FUDAN UNIVERSITY SHANGHAI CANCER CENTER Sister Institutions since 2003

Aims 目的 n Evaluate herbal/natural product treatments that target disease outcomes and treatment- and disease-related symptoms. （评价中草药或天然药物作用） n Determine the effects of acupuncture on specific clinical symptoms in patients with cancer. （针灸在肿瘤病人症状控制中的作用） n Quantify the biobehavioral effects of qigong and other mind/body-based interventions. （量化气功及其他意念 干预对机体生物学行为的影响） n Examining the reliability and validity of TCM diagnostic techniques. （中医诊断技术信度和效度研究）

U 19 International Center of TCM for Cancer Projects Dr. Lorenzo Cohen, Principal Investigator; Co-Director Hua. Chan. Su Dr. Zhiqiang Meng, Dr. David Chang Project Leaders Qigong Dr. Zhen Chen, Dr. Lorenzo Cohen Project Leaders Acupuncture K 1 Dr. Luming Liu, Dr. Joseph Chiang Project Leaders Acupuncture Xerostomia Dr. Zhiqing Meng, Dr. Joseph Chiang Project Leaders Dr. Luming Liu, Co-Principal Investigator Co-Director Cores Administrative Dr. Lorenzo Cohen, Dr. Luiming Liu Core Leaders Research Steering Committee Dr. Joseph Chiang Dr. Lynn Palmer Dr. Kay Garcia Dr. Lorenzo Cohen Dr. David Chang Dr. Luming Liu Dr. Razelle Kurzrock Dr. Zhiqing Meng Dr. Zhongxing Liao Dr. Zhen Chen Dr. Peiying Yang Dr. Yehua Shen Dr. Qingyi Wei Dr. Huiting Peng Dr. Chaosu Hu Biostatistics Dr. Lynn Palmer, Dr. Genming Zhao Core Leaders Epidemiology Dr. Qingyi Wei, Dr. Zhen Core Leaders

Preclinical Evaluation and Phase I and II Trial of Hua. Chan. Su in Pancreatic Cancer 华蟾素抗癌的临床前评估和I期临床研究

Huachansu or Ch’an su n Bufo toads excrete from their parotid glands substances known as bufotoxins. n Bufalin is one such toxin known to be a cardiac glycoside. n Huachansu is an important component in the treatment of cancer in China.

Phase I Results n Side effects were uncommon n 73% of patients with no drug related toxicity n Stable disease in 40% (n=6) n Indication of tumor regression at Level 1 n Qo. L improvement in patients with stable disease

Jun 9, 2005 Jul 20, 2005 Sep 6, 2005 Meng et al. , Cancer, 2009

针灸项目 Acupuncture 针灸预防术后麻痹性肠梗阻的研究 Acupuncture research for postoperative paralytic ileus after colorectal surgery 针刺预防放疗后口干的临床研究 Acupuncture for the prevention of radiationinduced xerostomia 电刺激预防介入后恶心呕吐的研究 Effects of acupoint electro-stimulation on preventing nausea and vomiting induced by cisplatin or oxaliplatin

SYMPTOMS SALIVA FLOW

气功项目 Qigong n 将在肿瘤医院开展一项气功的预试验：确定生物行为学研究的可行性 A pilot study of qigong is being conducted to determine the feasibility of conducting biobehavioral research at the Cancer Hospital. n 确定乳腺癌患者放疗期间练习气功的可接受性与可行性：已结束，正 在进行数据分析 Examine the feasibility and initial efficacy of implementing a Qigong program for patients with breast cancer as an adjuvant to their radiotherapy. The study was recently completed and the data is being analyzed.

Adjusted Means Center for Epidemiologic Studies Depression Scale (CES-D) Timepoint Means adjusted for baseline Group x time interaction p < 0. 05

流行病学研究Epidemiology n 建立方法学：检测TCM诊断技术的信度和效度 Establish a methodology to examine reliability and validity of TCM diagnostic techniques. n 确定可能的遗传易感性和预后的标志：与TCM诊断 和治疗相关 Identify markers for genetic susceptibility and prognosis that may be associated with TCM diagnosis and TCM treatment of cancer.

Cooperation(研究计划) 4 TCM protocols (herbs, acupuncture, Qigong) （4个中医课题，包括 中药、针灸、气功） Staff training （职员培训）

Education and Training Research training, long-term exchange, TCM training, unique opportunities

Education and Training One of the most critical factors to the success of the Center! n n All personnel directly involved with research activity at the Center were trained at MDACC n MDACC quality research nurses! n Faculty members Clinical, laboratory, and protocol

Clinical Research Training at MDACC n Formal IRB training course – MDACC standard - 2 -3 day seminar covers regulatory, ethics, data collection and monitoring issue of clinical research n CRC protocol scientific review and IRB meetings n Actual clinical protocol implementation in Phase I research group - shadowing doctors and nurses n Research coordinators (behavioral science, acupuncture) n Other MDACC supported training opportunities (Excel, Access, etc)

TCM Training n Many faculty members of the Center from MDACC already have some or extensive training in TCM n Educating all collaborators at MDACC in aspects of TCM theory n Long-term exchanges and internships

Training Summary n n This observation and training program has been highly successful and has resulted in the smooth running of the research studies being conducted at the ICIO. The highly competent staff has taken the knowledge from this experience and translated it into solid research. The training program we developed is effective in preparing nurses to oversee clinical research. The team is now able to critically evaluate study designs and data analyses while maintaining a level of integrity and professionalism that will result in world-class research. n 培训计划非常成功，ICIO的课题 顺利开展 n 经过培训的人员十分胜任科研 作，并能在课题实施过程中理论 联系实际 n 培训计划十分有效，经过培训的 科研护士可以监管整个临床研究 n 研究团队已经能够严密评价研究 设计、进行数据分析，并达到了 国际认可并接受的世界一流研究 水平 n 研究成员能科学地评价课题及其 对患者的影响

M. D. Anderson 癌症中心 n Lorenzo Cohen, Ph. D. n Razelle Kurzrock, M. D. n Zhongxing Liao, M. D. n Peiying Yang, Ph. D. n J. Lynn Palmer, Ph. D n n Qingyi Wei, M. D. , Ph. D. Mark Chambers, D. M. D. , M. S. n Chaan Ng, M. D. n Asif Rashid, M. D. n David Chang, M. D. , Ph. D. n Bob Thornton, M. A. n Qi Wei, M. A. n n n Joseph Chiang, M. D. Kay Garcia, Dr. P. H. , M. S. N. , R. N. , L. Ac. Robert Newman, Ph. D.

上海中医药大学：上海市气功研究所Shanghai University of TCM: Shanghai Qigong Institute n 储维忠, M. A. 林泉宝, M. A. 上海中医药大学诊断教研室 Teaching and Research Office of TCM Diagnosis, Shanghai University of TCM n 王忆勤，Ph. D n 燕海霞, M. A. 林慈斌，M. A

复旦大学公共卫生学院 Fudan University School of Public Health n 赵根明 n 赵琦 n 赵耐青

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