The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer Institute Dial In: 888-324-6921.

The NCI Office of Cancer Centers Learning Series

Complementary and Alternative Medicine Cancer Research and the National Cancer Institute

Dial In: 888-324-6921Passcode: Cancer Centers

For Technical Support, call 800-857-8777

and choose option 3.


Complementary and Alternative Medicine Cancer Research and the

National Cancer Institute Tuesday, September 11, 2012

2:00 to 3:00 pm EDT

ModeratorShannon Silkensen, Ph.D.

Program Director

Office of Cancer Centers

National Cancer Institute

National Institutes of Health

Bethesda, MD

Featured Presenters

Jeffrey D. White, M.D.Director, Office of Cancer Complementary and Alternative Medicine (OCCAM)

Division of Cancer Treatment and Diagnosis, NCI

Dan Xi, Ph.D.

Program Director, Office of Cancer Complementary and

Alternative Medicine (OCCAM)


Lorenzo Cohen, Ph.D.

Professor and Director of the Integrative Medicine Program

MD Anderson Cancer Center, Houston, TX

A 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.

NCI’s Complementary and Alternative

Medicine Activities: A Brief Overview

Cancer Centers WebinarSeptember 11, 2012

Jeffrey D. White, M.D.Director, Office of Cancer Complementary

and Alternative Medicine, NCI

Terminology 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)

Terminology and Definitions

Complementary and Alternative Medicine (CAM) – Complementary – Used in combination

with conventional treatment– Alternative – Used instead of

conventional treatment

Integrative Medicine– Combination of conventional (Western)

medicine and components of other medical traditions or other unconventional modalities with sufficient evidence-based support.

Major 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 Therapy– Electromagnetic (e.g.

electrochemotherapy)– Theoretical (e.g. Reiki, Qi gong)

• Exercise– Western forms (e.g. aerobic, isometric)– Other (e.g. T’ai Chi, yoga)

• Manipulative and Body-Based Therapies (Therapeutic massage, Osteopathy, Chiropractice)

Major 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 Therapies

– Complex 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 Healing• Miscellaneous

– Chronobiology and Chronotherapy

Comparative analysis of CAM use by the U.S. Cancer and Non-Cancer populations*

• Secondary analysis of the 2002 NHIS Survey

• 31,044 respondents– 28,734 individuals without prior CA diagnosis– 2,262 cancer survivors

• 461 diagnosed within the last 12 months• 1786 diagnosed > 12 months prior

• Results:– 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)

NCI’s Annual Report on Complementary and Alternative

Medicine 2010

PDF version is available on the OCCAM website (http://cancer.gov/cam)

NCI’s CAM Expenditures Fiscal Years 2003-2010

From: NCI’s Annual Report on Complementary and Alternative Medicine: Fiscal Year 2010, NIH Publication No. 11-7768, Feb. 2012

NCI’s Cancer CAM Portfolio FY2010

• Overview– > 400 projects, approx. $114.4 million– Extramural - Grants, cooperative

agreements and contracts• Diffusely represented throughout

portfolios of the four grant making extramural divisions (DCB, DCCPS, DCP, DCTD) – Over 50 different PDs

– Intramural (CCR and DCEG) – Projects and contracts

CCR = 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

From: NCI’s Annual Report on Complementary and Alternative Medicine: Fiscal Year 2010, NIH Publication No. 11-7768, Feb. 2012

NCI CAM Research Projects by CAM Category

Office of Cancer Complementary and

Alternative Medicine, NCIOCCAM established in October 1998 • Director: 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 20892

• Program Areas: Grant PortfolioCommunications and OutreachPractice Assessment

Mission of OCCAM

• To 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.

OCCAM’s International Research Collaborations

OCCAM 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 of mouse 4T1 mammary tumor cells.

The inhibitory effect of whole SQF extracts on mouse 4T1 tumor cell is greater than its individual major ingredients or the combination of major ingredients.

SQF treatment up-regulated pro-apoptosis genes (Bad and Apaf1), and down-regulated anti-apoptosis gene Bcl2.

OCCAM supported NCI – Kunming Institute of Botany (KIB) Anti-cancer Agents Screening Project

- Established collaboration in October 2008, an MOU was signed

between NCI and KIB.- Compounds from KIB were sent to NCI to start the

anti-cancer activity screening on NCI 60 human cancer cell

lines in 2009.- Total of 58 compounds have been screened on NCI

60.- 36 single concentration screening- 11 compounds had 5 conc. Screening- None to animal testing

- Molecular Targets Development Program has also investigated these compounds assays examining effects on specific cellular signaling pathways, such as TRAIL, AP-1, HIF-2

OCCAM supported NCI – Key Laboratory of Chemistry for Natural Products of Guizhou

Anti-cancer Agents Screening Project

- Established 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.

Communications and Outreach Program

Communications and Outreach Program

Promotes NCI CAM research activities, events, and initiatives

• Develops print and online information products on cancer CAM for healthcare professionals and the general public, including the website: http://www.cancer.gov/cam.

• NCI Annual Report on Complementary and Alternative Medicine

• CAM PDQ support• Research/practitioner

listserv for NCI CAM related events and news

• Invited lecturers

• NCI CAM News, our twice-yearly newsletter

• Patient Education resources



Questions?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.



NCI Cancer CAM Funding Opportunities and Grant writing

Dan Xi, Ph.D.

Program Director

([email protected])

Office of Cancer Complementary and Alternative Medicine (OCCAM)

National Cancer Institute (NCI)

National Institutes of Health (NIH)(http://www.cancer.gov/cam/index.html)

Objectives

To 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

Research Grant Funding and Portfolio at OCCAM, NCI

• Major Functions:• Analyze NCI cancer CAM portfolio• Identify gaps in existing cancer CAM research • Develop evidence-based scientific foundation of the field• Create and expand funding opportunities to stimulate high

quality research in cancer CAM• Provide technical assistance to applicants• Manage grants of cancer CAM interventions for treatment• Coordinate the cancer CAM grant activities at NCI

• Program Philosophy: Keep CAM research integrated within the relevant NCI scientific programs (e.g. prevention, symptom management and supportive care, survivorship and behavioral medicine etc.)

OCCAM’s Research Priorities

• Identifying novel therapeutics in the pharmacopeia of traditional medical systems as defined by the World Health Organization

• Using complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapies

• Research on lifestyle modifications (e.g. diet, exercise, mind-body approaches) for their impact on cancer outcomes (e.g. response to conventional cancer therapy, survival)

Types of NIH Grant Funding Programs(http://grants.nih.gov/grants/funding/funding_program.htm)

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 project • NIH's most commonly used grant program • No specific dollar limit unless specified in FOA • Advance permission required for $500K or more (direct costs) in any year • Generally awarded for 3 -5 years • NCI use NIH parent FOA: PA-11-260 (http://grants.nih.gov/grants/guide/pa-

files/PA-11-260.html)

OCCAM Active Grant Portfolio 2011-2012 (R01)

Project Number Project Title Principal Investigator Institution Project Start Project EndR01CA131151 A novel and targeted SARKAR, FAZLUL H. WAYNE STATE UNIVERSITY 7/1/2008 5/31/2013

approach to inhibitinvasion and angiogenesis

R01CA125262 Chemoprevention of SRIVASTAVA, RAKESH K. UNIVERSITY OF KANSAS 9/15/2008 7/31/2013Pancreatic Cancer by EGCG MEDICAL CENTER

R01CA157477 Mechanistic Studies on Prostate Cancer Prevention by Gugulipid

XIAO, DONG UNIVERSITY OF PITTSBURGH AT PITTSBURGH

9/10/2012 8/31/2015

R01CA044722 Vitamin D Analogs as Adjuvants in Chemotherapy of Cancer

STUDZINSKI, GEORGE P UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY

pending award

Types 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 funding • Combined budget for direct costs for the two year project period usually may not

exceed $275,000. • No preliminary data is generally required • See NCI specific PAR-12-145

R03 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 funding • Direct costs generally up to $50,000 per year • Not renewable • See NCI specific PAR-12-144

Project Number Project Title Principal Investigator Institution Project Start Project EndR21CA155518 Soy isoflavones to augment HILLMAN, GILDA G WAYNE STATE UNIVERSITY 9/19/2011 8/31/2013

radiotherapy of lungcarcinoma

R21CA161182 Using Ketogenic Diets to SPITZ, DOUGLAS ROBERT UNIVERSITY OF IOWA 9/15/2011 8/31/2013Enhance Radio-Chemo-TherapyResponse: A Phase I Trial

R21CA138277 Ginger Extract: SANG, SHENGMIN NORTH CAROLINA AGRI 9/1/2008 8/31/2012Bioavailability Study and & TECH ST UNIVLung Cancer Preventive Effect

OCCAM Active Grant Portfolio 2011-2012 (R21)

Project Number Project Title Principal Investigator Institution Project Start Project EndP01CA154295 Chinese Herbal Medicine as CHENG, YUNG-CHI YALE UNIVERSITY 9/15/2011 8/31/2016

a Novel Paradigm for CancerChemotherapy

R13CA144223 International Conference JOHNSTONE, PETER A S INDIANA UNIV-PURDUE UNIV 9/1/2011 8/31/2012for the Society for AT INDIANAPOLISIntegrative Oncology

Other OCCAM Active Grant Portfolio 2011-2012 (P01 and R13)

P01: Research Program Project Grant• Support for integrated, multi-project research projects involving a number of independent

investigators who share knowledge and common resources • Each 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 goal

• See NCI specific FOA: PAR-12-005 (http://grants.nih.gov/grants/guide/pa-files/PAR-12-005.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 health • Requires advance permission from the funding IC • Foreign institutions are not eligible to apply • See NIH parent FOA: PA-12-212

Other 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.

Project Number Project Title Principal Investigator Institution Project Start Project EndU01CA063477 Nucleoside Analogs as CHENG, YUNG-CHI YALE UNIVERSITY 8/1/1996 6/30/2011

Anticancer Compounds

U01CA166800 Ascorbate-induced radiosensitization in pancreatic cancer

CULLEN, JOSEPH J UNIVERSITY OF IOWA 8/3/2012 7/31/2014

U19CA121503 International Center of TCM COHEN, LORENZO UNIVERSITY OF TEXAS 9/30/2005 8/31/2011for Cancer MD ANDERSON CAN CTR

U19CA128534 International Center for the EISENBERG, DAVID M HARVARD UNIVERSITY 9/22/2006 7/31/2011Evaluation of East Asian (MEDICAL SCHOOL)Botanicals for Cancer

Planning, Writing, Submitting

Planning: Applicant

should start early, collect preliminary data, and determine internal deadlines.

Writing: Applicant often begins writing application several months prior to application due date.

Submitting: Applicant organization submits most applications to NIH through Federal portal, Grants.gov.

Receipt and Referral

Applications

compliant with NIH policies are assigned for review by the Division of Receipt and Referral in the Center of Scientific Review (CSR).

CSR assigns application to an NIH Institute/Center (IC) and a Scientific Review Group (SRG).

Scientific Review Officer (SRO) assigns applications to reviewers and readers.

Grants Process At-a-Glance (http://grants.nih.gov/grants/grants_process.htm)

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.

I nitial Level of Review: SRG members review and evaluate applications for scientific merit.

Impact Scores: Available to Principal Investigator on eRA Commons.

Summary Statement: Available to Principal Investigator on eRA Commons.

Second Level of Review: Advisory council/board reviews applications.

Peer Review

Award

Pre-Award

Process: IC grants management staff conducts final administrative review and negotiates award.*

Notification of Award: NIH Institute/Center (IC) director makes funding decision. IC staff issues and sends Notice of Award (NoA) to applicant institution/organization.

Congratulations!

Project period officially begins!

*NIH Requests additional information needed just- in-time for award.

Grants Process At-a-Glance (continued)

Funding Opportunity Announcements Related to Cancer CAM

(http://www.cancer.gov/cam/research_funding_apa.html)

1. NCI-wide Funding Opportunities *new* (R21 and R03)

2. OCCAM Participating Announcements

3. Behavioral/ Mind-Body

4. Diet, Nutrition & Physical Activity

5. Symptom Management

6. Survivorship *new*

7. Miscellaneous

NCI-wide Funding Opportunities *new*

NCI Exploratory/ Developmental Research Grant Program (NCI Omnibus R21)

PAR-12-145 Released: 3/29/2012

Expires: 9/8/2015

NCI Small Grants Program for Cancer Research (NCI Omnibus R03)

PAR-12-144 Released: 3/29/2012

Expires: 9/8/2015


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 http://www.cancer.gov/researchandfunding/extramural]. 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.

OCCAM Participating Announcements

Limited Competition: Fogarty International Research Collaboration - Basic Biomedical (FIRCA-BB) Research Award (R03)

PAR-11-037

Released: 11/17/2010

Expires: 1/11/2013

Biology of Manual Therapies (R01) PA-10-209

Released: 5/27/2010

Expires: 1/8/2014

Biology of Manual Therapies (R21) PA-10-210

Released: 5/27/2010

Expires: 1/8/2014

Behavioral/ Mind-Body

Small Grants for Behavioral Research in Cancer Control (R03)

PAR-12-035 Released: 12/22/2011

Expires: 10/19/2012


Diet, Nutrition & Physical Activity

Physical activity and weight control interventions among cancer survivors: Effects on biomarkers of prognosis and survival (R01)

PAR-12-228 Released: 7/10/2012

Expires: 9/8/2015

Physical activity and weight control interventions among cancer survivors: Effects on biomarkers of prognosis and survival (R21)

PAR-12-229 Released: 7/10/2012

Expires: 9/8/2015

Improving Diet and Physical Activity Assessment (R01) PAR-12-198 Released: 6/6/2012

Expires: 9/8/2015

Improving Diet and Physical Activity Assessment (R21) PAR-12-197 Released: 6/6/2012

Expires: 9/8/2015

Exploratory/ Developmental Clinical Research Grants in Obesity (R21)

PA-12-179 Released: 5/2/2012

Expires: 5/8/2015

Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21)

PA-12-139 Released: 3/23/2012

Expires: 5/8/2015

Enhancing Tumoricidal Activity of Natural Killer (NK) Cells by Dietary Components for Cancer Prevention (R01)

PA-11-160 Released: 3/17/2011

Expires: 5/8/2014

Enhancing Tumoricidal Activity of Natural Killer (NK) Cells by Dietary Components for Cancer Prevention (R21)

PA-11-161 Released: 3/17/2011

Expires: 5/8/2014

The Role of Microbial Metabolites in Cancer Prevention and Etiology (U01)

PAR-11-152 Released: 3/15/2011

Expires: 11/16/2012

Nutrition and Alcohol-Related Health Outcomes (R01) PA-10-239 Released: 7/30/2010

Expires: 9/8/2013


Expires: 9/8/2013


Expires: 9/8/2013

Exploratory Cancer Prevention Studies Involving Molecular Targets for Bioactive Food Components (R21)

PA-10-088 Released: 3/17/2010

Expires: 5/8/2013

Diet Composition and Energy Balance (R01) PA-10-152 Released: 3/24/2010

Expires: 5/8/2013

Prioritizing Molecular Targets for Cancer Prevention with Nutritional Combinations (R01)

PA-10-035 Released: 11/24/2009

Expires: 1/8/2013


Symptom Management

Mechanisms, Models, Measurement, & Management in Pain Research (R01)

PA-10-006 Released: 10/5/2009

Expires: 1/8/2013


PA-10-007 Released: 10/5/2009

Expires: 1/8/2013


PA-10-008 Released: 10/5/2009

Expires: 1/8/2013

Survivorship

Examination of Survivorship Care Planning Efficacy and Impact [R01]

PA-12-275 Released: 8/29/2012

Expires: 1/8/2016

Examination of Survivorship Care Planning Efficacy and Impact [R21]

PA-12-274 Released: 8/29/2012

Expires: 1/8/2016

Miscellaneous

Research Project Grant (Parent R01) PA-11-260 Released: 07/22/2011

Expires: 9/8/2014

NCI Program Project Application (P01) PAR-09-025

Released: 10/21/2011

Expires: 1/8/2015

NIH Support for Conferences and Scientific Meetings (Parent R13/U13)

PA-12-212 Released: 6/19/2012

Expires: 9/8/2014


Grant Application Information(http://www.cancer.gov/cam/research_applying.html)

• Research Priorities: -OCCAM Research Priorities; -NCI Research Priorities

• Tips 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 grant

• Expert 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 proposals

• Grant Application and Review Process: web links to NCI and NIH

• Information for Grantees

• Research Policies

• Frequently Asked Questions about Research(http://www.cancer.gov/cam/research_faqs.html)

Frequently 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 complexity

• Set realistic and not overly ambitious specific aims

• Create a clear conceptual model

• Strive for a well-defined methodology

• Note the validity and replicability of the project

• Cite background studies and references

• Discuss statistical expertise and provide a clear data analysis plan

• Have a plan for quality assurance

• Note the expertise of investigator teams

Additionally, 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: http://grants1.nih.gov/grants/grant_tips.htm

•NCI Grant Application and Review Process http://www.cancer.gov/researchandfunding/grantprocess

Frequently 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: http://cms.csr.nih.gov/

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: http://www.csr.nih.gov/Roster_proto/sectionI.asp

•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)

Thank You




Dan Xi, Ph.D.




46

Lorenzo Cohen, PhD

Director, Integrative Medicine Program

Traditional Chinese Medicine and Other Research Opportunities in Integrative Oncology

International Center of Traditional Chinese Medicine for Cancer

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

• R21 (CA108084, NCI)• U19 (CA121530, NCI)

47

Aims

Evaluate 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.

48

49

International Center of Integrative Oncology (ICIO)

Established September 2003

Cooperation

7 TCM Clinical Trials Staff training • 2 Natural products• 4 Acupuncture• 1 Qigong

50

51

Dr. Lorenzo Cohen, Principal Investigator;

Co-Director

Dr. Luming Liu, Co-Principal Investigator

Co-Director

Research 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

Acupuncture Xerostomia (Two

Trials)Dr. Zhiqing Meng,Dr. Joseph Chiang

Project Leaders

Phase I and II Trials of HuaChanSu

Dr. Zhiqiang Meng,Dr. David ChangProject Leaders

Acupuncture K1 Dr. Luming Liu,

Dr. Joseph ChiangProject Leaders

QigongDr. Zhen Chen,

Dr. Lorenzo CohenProject Leaders

Projects

AdministrativeDr. Lorenzo Cohen,

Dr. Luiming LiuCore Leaders

Epidemiology Dr. Qingyi Wei,Dr. Zhen ChenCore Leaders

BiostatisticsDr. Lynn Palmer,

Dr. Genming Zhao

Core Leaders

Cores

Acupuncture IleusDr. Zhiqing Meng,Dr. Joseph Chiang

Project Leaders

HuaCanSu Preclinical Research

Dr. Peiying Yang,Dr. Zhiqiang Meng,

Project Leaders

International Center of TCM for Cancer

52

Preclinical Evaluation and Phase I and II Trial of HuaChanSu

53

Pilot Study of Hauchansu Patients with Hepatocellular Carcinoma, Nonsmall-Cell

Lung Cancer, or Pancreatic Cancer

Examples of Acupuncture

55

Acupuncture

Acupuncture 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 oxaliplatin

Acupuncture for the prevention of radiation-Induced xerostomia (Meng et al., Cancer, 2011;Meng et al., Euro J Cancer, 2012)

56

Ongoing Research ProjectsAcupuncture

• 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)

57

Ongoing 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 biopsy

58

Catharanthus roseus (Periwinkle) Vinblastine

Camptotheca acuminata (Happy Tree) Irinotecan

Taxus brevifolia (Yew Tree) Paclitaxel

Podophyllum pelatum (Mayapple)Etoposide

Natural Products are a Common Source of Chemotherapeutic Agents

Natural Products Being Investigated in Dr. Peiying Yang’s Laboratory for Prevention and Treatment of Cancer

• Fish 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)

Considerations• Grantsmanship

– Pilot data– Feasibility– Significance

• Study sections– Behavioral Medicine, Interventions and Outcomes

(BMIO)– Mechanisms of Emotion, Stress and Health (MESH) – Chemo/Dietary Prevention (CDP)

• Program Officers

Integrative Oncology Healthcare Professional Training Conference












Dan Xi, Ph.D.







Disclosures

•Jeffrey D. White, M.D.: Financial disclosure.

•Dan Xi, Ph.D.: Financial disclosure.

•Lorenzo Cohen, Ph.D.: Financial disclosure.

.



If you have further questions, please contact

Elizabeth Austin

[email protected]

This webinar was created by the Office of Cancer Centers in the National Cancer Institute

http://cancercenters.cancer.gov/

For information about the NCI’s Office of Cancer Complementary and Alternative Medicine, please visit http://dctd.cancer.gov/ProgramPages/occam/default.htm

NCI’s Cancer Information Service

• Offers comprehensive, research-based information in English and Spanish for patients, the public, health professionals, and cancer researchers

• Phone: 1-800-4-CANCER• Online Chat: www.cancer.gov/livehelp• Email: [email protected]• Web: www.cancer.gov and

www.cancer.gov/espanol• Facebook: Facebook.com/cancer.gov

The NCI Office of Cancer Centers Learning Series Complementary and Alternative Medicine Cancer Research and the National Cancer Institute Dial In: 888-324-6921.

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cancer diagnosis

office of cancer complementary

cancer therapies

cancer survivors

cancer epidemiology

cancer control

cancer patients

cancer research dcb