Presentation on theme: "4/2/2017 The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer Institute Dial."— Presentation transcript:
14/2/2017The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer InstituteDial In:Passcode: Cancer Centers For Technical Support, call and choose option 3.National Cancer Institute
2The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer InstituteTuesday, September 11, 20122:00 to 3:00 pm EDTModeratorShannon Silkensen, Ph.D.Program DirectorOffice of Cancer CentersNational Cancer InstituteNational Institutes of HealthBethesda, MDFeatured PresentersJeffrey D. White, M.D. Director, Office of Cancer Complementary and Alternative Medicine (OCCAM)Division of Cancer Treatment and Diagnosis, NCIDan Xi, Ph.D.Program Director, Office of Cancer Complementary andAlternative Medicine (OCCAM)Lorenzo Cohen, Ph.D.Professor and Director of the Integrative Medicine ProgramMD Anderson Cancer Center, Houston, TX
3A Quick Guide to Your Screen Please submit your question via the Q & A box on the right hand side of your screen. If you do not see the Q&A box, you can expand it by clicking the Q&A on the top navigation panel and dragging the box that opens to the right side of your screen.
44/2/2017NCI’s Complementary and Alternative Medicine Activities: A Brief OverviewCancer Centers Webinar September 11, Jeffrey D. White, M.D. Director, Office of Cancer Complementary and Alternative Medicine, NCINational Cancer Institute
5Terminology and Definitions Complementary and Alternative Medicine (CAM)“Medical and health care practices that are not an integral part of conventional (Western) medicine.” (National Center for Complementary and Alternative Medicine)“…a broad set of health care practices that are not part of that country’s own tradition and are not integrated in the dominant health care system.” (World Health Organization)
6Terminology and Definitions Complementary and Alternative Medicine (CAM)Complementary – Used in combination with conventional treatmentAlternative – Used instead of conventional treatmentIntegrative MedicineCombination of conventional (Western) medicine and components of other medical traditions or other unconventional modalities with sufficient evidence-based support.
7Major Domains of Complementary and Alternative Medicine Research (NCI, OCCAM) Alternative Medical Systems and some of their components (e.g. Traditional Chinese Medicine, Homeopathy, acupuncture)Energy TherapyElectromagnetic (e.g. electrochemotherapy)Theoretical (e.g. Reiki, Qi gong)ExerciseWestern forms (e.g. aerobic, isometric)Other (e.g. T’ai Chi, yoga)Manipulative and Body-Based Therapies (Therapeutic massage, Osteopathy, Chiropractice)
8Major Domains of Complementary and Alternative Medicine Research (NCI, OCCAM) Mind-Body Interventions (e.g. hypnosis, imagery, relaxation therapy)Nutritional Therapeutics (e.g. diet modification, specific foods, nutrients, bioactive food components)Pharmacological and Biologically-based TherapiesComplex natural products (e.g. botanicals, extracts from marine animals [e.g. shark cartilage])Off-label use of certain drugs not traditionally used as cancer therapies (e.g. naltrexone)Spirituality and Spiritual HealingMiscellaneousChronobiology and ChronotherapyThings we capture in the definition which may be controversial:Circadian rhythms, chronomodulated chemotherapyOff label uses of certain drugs – e.g. NaltrexoneUnconventional approaches to the augmentation of chemotherapy effect – e.g. insulin potentiation therapy, nutrient supplementation or depletionDiet as a primary or adjuvant therapy for cancer – e.g. Women’s Intervention Nutrition Study (WINS)PsychoneuroimmunologyPotential Opportunities:Things in use in other countries but not studied or rarely studied in the U.S. – e.g. beta glucansPotential Approaches to Augment the Effect of Conventional Cancer Therapies – E.g. psychoneuroimmunology, exercise – chemotherapy or immune therapiesVitamin C, intravenous, high-dose
9Comparative analysis of CAM use by the U. S Comparative analysis of CAM use by the U.S. Cancer and Non-Cancer populations*Secondary analysis of the 2002 NHIS Survey31,044 respondents28,734 individuals without prior CA diagnosis2,262 cancer survivors461 diagnosed within the last 12 months1786 diagnosed > 12 months priorResults:Cancer survivors use CAM more frequently than individuals without a cancer diagnosis (39.2% vs. 34.9%, p<0.001*Fouladbakhsh JM, Strommel M. Journal of Complementary and Integrative Medicine 2008;5(1): Art. 19 (Epub)
10NCI’s Annual Report on Complementary and Alternative Medicine 2010 PDF version is available on the OCCAM website (http://cancer.gov/cam)
11NCI’s CAM Expenditures Fiscal Years 2003-2010 From: NCI’s Annual Report on Complementary and Alternative Medicine: Fiscal Year 2010, NIH Publication No , Feb. 2012
12NCI’s Cancer CAM Portfolio FY2010 Overview> 400 projects, approx. $114.4 millionExtramural - Grants, cooperative agreements and contractsDiffusely represented throughout portfolios of the four grant making extramural divisions (DCB, DCCPS, DCP, DCTD) – Over 50 different PDsIntramural (CCR and DCEG) – Projects and contractsCCR = Center for Cancer Research; DCB = Div. of Cancer Biology; DCEG = Div. of Cancer Epidemiology and Genetics; DCP = Div. of Cancer Prevention; DCCPS = Div. of Cancer Control and Pop. Sciences; DCTD = Div. of Cancer Treatment and Diagnosis
13NCI CAM Research Projects by CAM Category From: NCI’s Annual Report on Complementary and Alternative Medicine: Fiscal Year 2010, NIH Publication No , Feb. 2012
14Office of Cancer Complementary and Alternative Medicine, NCI OCCAM established in October 1998Director: Jeffrey D. White, M.D.Organizational Location: Division of Cancer Treatment and Diagnosis (Formerly in the Office of the Director)Physical Location: 6116 Executive Blvd., Suite 609, Bethesda, MD 20892Program Areas:Grant PortfolioCommunications and OutreachPractice Assessment
15Mission of OCCAMTo improve the quality of care of cancer patients, as well as those at risk for cancer and those recovering from cancer treatment, by contributing to the advancement of evidence-based CAM practice, the sciences that support it and to the availability of high-quality information for the healthcare community, researchers and the general public.
17OCCAM supported NCI – Beijing Guang’anmen Hospital Traditional Chinese Medicine Study Project The collaborative study of TCM Shen Qi Formula (SQF) - an extract from two herbs: Astragalus mongholicus Bge, and Panax notoginseng) - has found:SQF has direct inhibitory effect on the proliferation ofmouse 4T1 mammary tumor cells.The inhibitory effect of whole SQF extracts on mouse4T1 tumor cell is greater than its individual majoringredients or the combination of major ingredients.SQF treatment up-regulated pro-apoptosis genes(Bad and Apaf1), and down-regulated anti-apoptosisgene Bcl2.
18OCCAM supported NCI – Kunming Institute of Botany (KIB) Anti-cancer Agents Screening Project Established collaboration in October 2008, an MOU was signedbetween NCI and KIB.Compounds from KIB were sent to NCI to start the anti-canceractivity screening on NCI 60 human cancer cell lines in 2009.Total of 58 compounds have been screened on NCI 60.36 single concentration screening11 compounds had 5 conc. ScreeningNone to animal testingMolecular Targets Development Program has also investigated these compounds assays examining effects on specific cellular signaling pathways, such as TRAIL, AP-1, HIF-2
19OCCAM supported NCI – Key Laboratory of Chemistry for Natural Products of Guizhou Anti-cancer Agents Screening ProjectEstablished collaboration on anti-cancer agents screening in December 2009.An MOU was singed between NCI and Key Lab of Chemistry for Natural Products (KLCNP) of Guizhou in March 2010.More than 200 compounds from KLCNP of Guizhou were sent to NCI to start the anti-cancer activity screening on NCI 60 human cancer cell lines in 2010.38 so far in one conc. testing and 3 on to 5 conc.KLCNP of Guizhou also sent 150 regional-specific herbal extracts to NCI in 2011 for potential anti-cancer activity screening.
21Communications and Outreach Program Promotes NCI CAM research activities, events, and initiativesDevelops print and online information products on cancer CAM for healthcare professionals and the general public, including the website:NCI Annual Report on Complementary and Alternative MedicineCAM PDQ supportResearch/practitioner listserv for NCI CAM related events and newsInvited lecturersNCI CAM News, our twice-yearly newsletterPatient Education resources
234/2/2017The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer InstituteQuestions?Please submit your question via the Q & A box on the right hand side of your screen. If you do not see the Q&A box, you can expand it by clicking the Q&A on the top navigation panel and dragging the box that appears it to the right side of your screen.Jeffrey D. White, M.D. Director, Office of Cancer Complementary and Alternative Medicine (OCCAM)Division of Cancer Treatment and Diagnosis, NCIBarbara A. Conley, MD has been Associate Director of the Cancer Diagnosis Program (CDP) in the NCI Division of Cancer Treatment and Diagnosis (DCTD)National Cancer Institute
24NCI Cancer CAM Funding Opportunities and Grant writing Dan Xi, Ph.D.Program DirectorOffice of Cancer Complementary and Alternative Medicine (OCCAM)National Cancer Institute (NCI)National Institutes of Health (NIH)(http://www.cancer.gov/cam/index.html)
25ObjectivesTo share information about the OCCAM/NCI cancer CAM portfolio, funding opportunities and initiatives in cancer CAM research, as well as some aspects on strategies for grant writing
26Research Grant Funding and Portfolio at OCCAM, NCI Major Functions:Analyze NCI cancer CAM portfolioIdentify gaps in existing cancer CAM researchDevelop evidence-based scientific foundation of the fieldCreate and expand funding opportunities to stimulate high quality research in cancer CAMProvide technical assistance to applicantsManage grants of cancer CAM interventions for treatmentCoordinate the cancer CAM grant activities at NCIProgram Philosophy: Keep CAM research integrated within the relevant NCI scientific programs (e.g. prevention, symptom management and supportive care, survivorship and behavioral medicine etc.)
27OCCAM’s Research Priorities Identifying novel therapeutics in the pharmacopeia of traditional medical systems as defined by the World Health OrganizationUsing complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapiesResearch on lifestyle modifications (e.g. diet, exercise, mind-body approaches) for their impact on cancer outcomes (e.g. response to conventional cancer therapy, survival)
28Types of NIH Grant Funding Programs (http://grants. nih The following represents some main types of grant funding programs in the cancer CAM research:R01: NIH Research Project Grant Program (R01)Used to support a discrete, specified, circumscribed research projectNIH's most commonly used grant programNo specific dollar limit unless specified in FOAAdvance permission required for $500K or more (direct costs) in any yearGenerally awarded for 3 -5 yearsNCI use NIH parent FOA: PA (http://grants.nih.gov/grants/guide/pa-files/PA html)OCCAM Active Grant Portfolio (R01)
29Types of NIH Grant Funding Programs R21: NIH Exploratory/Developmental Research Grant Award (R21)Encourages new, exploratory and developmental research projects by providing support for the early stages of project development. Sometimes used for pilot and feasibility studies.Limited to up to two years of fundingCombined budget for direct costs for the two year project period usually may not exceed $275,000.No preliminary data is generally requiredSee NCI specific PARR03 NIH Small Grant Program (R03):Provides limited funding for a short period of time to support a variety of types of projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self-contained research projects, development of new research technology, etc.Limited to two years of fundingDirect costs generally up to $50,000 per yearNot renewableSee NCI specific PAR
31Other OCCAM Active Grant Portfolio 2011-2012 (P01 and R13) P01: Research Program Project GrantSupport for integrated, multi-project research projects involving a number of independent investigators who share knowledge and common resourcesEach project contributes or is directly related to the common theme of the total research effort, thus forming a system of research activities and projects directed toward a well-defined research program goalSee NCI specific FOA: PAR (http://grants.nih.gov/grants/guide/pa-files/PAR html)R13: NIH Support for Conferences and Scientific Meetings (R13 and U13)Support for high quality conferences/scientific meetings that are relevant to NIH's scientific mission and to the public healthRequires advance permission from the funding ICForeign institutions are not eligible to applySee NIH parent FOA: PA31
32Other OCCAM Active Grant Portfolio 2011-2012 (U01 and U19) Cooperative Agreement (U Series) A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
33Grants Process At-a-Glance (http://grants. nih Any successful project requires planning, development, implementation, and follow-through. Obtaining NIH funding for your research idea is no exception. The Grants Process At-A-Glance Chart below provides an overview of the steps required for an application to proceed from application planning and submission through award and close out. Look to the related resources for special guidance from NIH experts that can help maximize your understanding of the grants process and help you submit a successful grant application.
35Funding Opportunity Announcements Related to Cancer CAM (http://www NCI-wide Funding Opportunities *new* (R21 and R03)OCCAM Participating AnnouncementsBehavioral/ Mind-BodyDiet, Nutrition & Physical ActivitySymptom ManagementSurvivorship *new*Miscellaneous
36Funding Opportunity Announcements Related to Cancer CAM Specific Research Objectives: All areas of cancer research relevant to the mission of the NCI are appropriate for projects submitted in response to this FOA [for a list of extramural research funding programs at the NCI, go to Projects proposed in response to this FOA may involve basic, translational, clinical, and/or population research. Examples of relevant areas include but are not limited to studies of: cancer biology; cancer control; cancer diagnosis; cancer disparities; cancer prevention; and cancer treatment.36
37Funding Opportunity Announcements Related to Cancer CAM 37
38Funding Opportunity Announcements Related to Cancer CAM 38
39Funding Opportunity Announcements Related to Cancer CAM 39
40Grant Application Information (http://www. cancer Research Priorities: -OCCAM Research Priorities; -NCI Research PrioritiesTips for Writing a Grant:Strategies for Success: How to Write a Cancer CAM Grant (PDF): Reviews issues unique to CAM related research areas and provides tips to writing a cancer CAM grantExpert Opinions on Methodology: Development of Cancer CAM Symptom Research (PDF): Identifies CAM research methodology challenges and proposes potential solutions to assist grant applicants with future cancer CAM research proposalsGrant Application and Review Process: web links to NCI and NIHInformation for GranteesResearch PoliciesFrequently Asked Questions about Research (http://www.cancer.gov/cam/research_faqs.html)
41Frequently Asked Questions about Grant Applications (http://www.cancer.gov/cam/research_faqs.html) Where can I find information and guidance on preparing a grant application?Preparing to submit a grant application can feel overwhelming. Here are some suggestions to avoid some of the common pitfalls of grant applications:Have a clear project description without complexitySet realistic and not overly ambitious specific aimsCreate a clear conceptual modelStrive for a well-defined methodologyNote the validity and replicability of the projectCite background studies and referencesDiscuss statistical expertise and provide a clear data analysis planHave a plan for quality assuranceNote the expertise of investigator teamsAdditionally, please visit these NIH and NCI websites for more broad information about grant writing and submission.NIH Office of Extramural Research Grant Writing Tips Sheets:NCI Grant Application and Review Process
42Frequently Asked Questions about Grant Applications (http://www.cancer.gov/cam/research_faqs.html) What review group would best fit the proposed application? Applicants can search for matching review groups at the following link:Can an applicant propose a study review group or IRG for their application? Below are some recommendations on how to write a cover letter to propose a specific study section for your application.Read about CSR Study Sections at:Identify an appropriate study section.You can propose in your cover letter where your application appears to have the best fit.You may suggest the inclusion of reviewers with specific scientific expertise.You can indicate the name of the Program Director who has provided you with technical assistance with the Branch/Office.Does NCI or OCCAM have a CAM-specific review Special Emphasis Group (SEP)? No. Applications are evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) and under the section of “Application Review Information” in the Funding Opportunity Announcement (FOA). Most of applications of CAM cancer research have been reviewed by Center for Scientific Review (CSR)
454/2/2017The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer InstituteQuestions?Please submit your question via the Q & A box on the right hand side of your screen. If you do not see the Q&A box, you can expand it by clicking the Q&A on the top navigation panel and dragging the box that appears it to the right side of your screen.Dan Xi, Ph.D.Program Director, Office of Cancer Complementary andAlternative Medicine (OCCAM)Division of Cancer Treatment and Diagnosis, NCIBarbara A. Conley, MD has been Associate Director of the Cancer Diagnosis Program (CDP) in the NCI Division of Cancer Treatment and Diagnosis (DCTD)National Cancer Institute
46Traditional Chinese Medicine and Other Research Opportunities in Integrative Oncology Lorenzo Cohen, PhDDirector, Integrative Medicine Program
47International Center of Traditional Chinese Medicine for Cancer Lorenzo Cohen, Ph.D., Principal Investigator/Co-DirectorLuming Liu, M.D., Co- Principal Investigator/Co-DirectorZhiqiang Meng, M.D., Ph.D., Deputy DirectorR21 (CA108084, NCI)U19 (CA121530, NCI)
48AimsEvaluate herbal/natural product treatments that target disease outcomes and treatment- and disease-related symptoms.Determine the effects of acupuncture on specific clinical symptoms in patients with cancer.Quantify the biobehavioral effects of qigong and other mind/body-based interventions.Examining the reliability and validity of TCM diagnostic techniques.
49International Center of Integrative Oncology (ICIO) Established September 2003
51International Center of TCM for Cancer Dr. Lorenzo Cohen,Principal Investigator;Co-DirectorDr. Luming Liu,Co-Principal InvestigatorCo-DirectorProjectsCoresPhase I and II Trials of HuaChanSuDr. Zhiqiang Meng,Dr. David ChangProject LeadersQigongDr. Zhen Chen,Dr. Lorenzo CohenProject LeadersAdministrativeDr. Lorenzo Cohen,Dr. Luiming LiuCore LeadersBiostatisticsDr. Lynn Palmer,Dr. Genming ZhaoCore LeadersHuaCanSu Preclinical ResearchDr. Peiying Yang,Dr. Zhiqiang Meng,Project LeadersAcupuncture Xerostomia (Two Trials)Dr. Zhiqing Meng,Dr. Joseph ChiangProject LeadersEpidemiologyDr. Qingyi Wei,Dr. Zhen ChenCore LeadersAcupuncture IleusDr. Zhiqing Meng,Dr. Joseph ChiangProject LeadersAcupuncture K1Dr. Luming Liu,Dr. Joseph ChiangProject LeadersResearch Steering CommitteeDr. Joseph Chiang Dr. Lynn PalmerDr. Kay Garcia Dr. Lorenzo CohenDr. David Chang Dr. Luming LiuDr. Razelle Kurzrock Dr. Zhiqing MengDr. Zhongxing Liao Dr. Zhen ChenDr. Peiying Yang Dr. Yehua ShenDr. Qingyi Wei Dr. Huiting PengDr. Chaosu Hu
52Preclinical Evaluation and Phase I and II Trial of HuaChanSu
53Pilot Study of Hauchansu Patients with Hepatocellular Carcinoma, Nonsmall-Cell Lung Cancer, or Pancreatic Cancer
55AcupunctureAcupuncture research for postoperative paralytic ileus after colorectal surgery (Meng et al., WJG, 2010)Effects of acupoint electro-stimulation on preventing nausea and vomiting induced by cisplatin or oxaliplatinAcupuncture for the prevention of radiation-Induced xerostomia (Meng et al., Cancer, 2011;Meng et al., Euro J Cancer, 2012)
56Ongoing Research Projects Acupuncture Xerostomia treatment (CCOP; R01)Xerostomia prevention (Multicenter R01)Neuropathy – Compare twice weekly versus three-times weekly acupuncture (Institutional Research Grant)Neuropathy – Evaluate electrical acupuncture and total treatments (Sister Institution Fund)Ensure that we start to truly practice integrative medicine and not just provide disjointed services.56
57Ongoing Research Projects Mind-body Mindfulness relaxation - general (CCOP)Tibetan yoga- breast cancer (R01)Tibetan sound meditation for chemobrain (R01 pending)Hatha yoga during xrt for breast cancer (R01)Qigong/Tai chi during xrt for rectal/prostate (R21)Neurofeedback for peripheral neuropathy (ACS)Guided meditation during breast biopsyEnsure that we start to truly practice integrative medicine and not just provide disjointed services.57
58Natural Products are a Common Source of Chemotherapeutic Agents Catharanthus roseus (Periwinkle)VinblastineTaxus brevifolia (Yew Tree)PaclitaxelCamptotheca acuminata (Happy Tree)IrinotecanPodophyllum pelatum (Mayapple)Etoposide
59Natural Products Being Investigated in Dr Natural Products Being Investigated in Dr. Peiying Yang’s Laboratory for Prevention and Treatment of CancerFish Oil/EPA – Anti-inflammatory/COX-2 - Lung Cancer Prevention (R01)Sweet Gum – PI3k/Akt/mTOR inhibitor – Prostate Cancer/HCC (R21 and Internal)Nerium Oleander (Anvirzel & PBI) - Lung and Pancreatic cancer (CCOP and Sponsored Research Agreement)Black cumin – Hepatocellular Carcinoma (Internal)Toad skin extract (Huachansu or TSO) – Lymphoma, HCC and pancreatic cancer (Foundation and Sponsored Research Agreement)
60Considerations Grantsmanship Study sections Program Officers Pilot dataFeasibilitySignificanceStudy sectionsBehavioral Medicine, Interventions and Outcomes (BMIO)Mechanisms of Emotion, Stress and Health (MESH)Chemo/Dietary Prevention (CDP)Program Officers
61Integrative Oncology Healthcare Professional Training Conference
624/2/2017The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer InstituteQuestions?Please submit your question via the Q & A box on the right hand side of your screen. If you do not see the Q&A box, you can expand it by clicking the Q&A on the top navigation panel and dragging the box that appears it to the right side of your screen.Lorenzo Cohen, Ph.D.Professor and Director of the Integrative Medicine ProgramMD Anderson Cancer Center, Houston, TXNational Cancer Institute
634/2/2017The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer InstituteQuestions?Please submit your question via the Q & A box on the right hand side of your screen. If you do not see the Q&A box, you can expand it by clicking the Q&A on the top navigation panel and dragging the box that appears it to the right side of your screen.Jeffrey D. White, M.D. Director, Office of Cancer Complementary and Alternative Medicine (OCCAM)Division of Cancer Treatment and Diagnosis, NCIDan Xi, Ph.D.Program Director, Office of Cancer Complementary andAlternative Medicine (OCCAM)Lorenzo Cohen, Ph.D.Professor and Director of the Integrative Medicine ProgramMD Anderson Cancer Center, Houston, TXNational Cancer Institute
64Disclosures Jeffrey D. White, M.D.: Financial disclosure. Dan Xi, Ph.D.: Financial disclosure.Lorenzo Cohen, Ph.D.: Financial disclosure..
65If you have further questions, please contact Elizabeth Austin 4/2/2017The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer InstituteIf you have further questions, please contactElizabeth AustinThis webinar was created by the Office of Cancer Centers in the National Cancer InstituteFor information about the NCI’s Office of Cancer Complementary and Alternative Medicine, please visitNational Cancer Institute
66NCI’s Cancer Information Service 4/2/2017NCI’s Cancer Information ServiceOffers comprehensive, research-based information in English and Spanish for patients, the public, health professionals, and cancer researchersPhone: CANCEROnline Chat:Web: andFacebook: Facebook.com/cancer.govNational Cancer Institute