FON Helps Integrative Health & Medicine Enterprises Grow.


Block Integrative Oncology Project

h5. The Block Integrative Oncology Project brings together stakeholders to create a new platform for developing comprehensive, evidence-based whole systems research.

The Block Integrative Oncology Project (BIOP) is an initiative of the Institute for Integrative Cancer Research and Education, a 501c3 non-profit research foundation. The project is positioned to bring together leading worldwide integrative oncology stakeholders—medical oncologists, hematologists, scientists, biostatisticians—and a group of foundations and philanthropists who support the next generation of innovative medical research. It brings the knowledge and experience of the Block Center for Integrative Cancer Treatment, a community-based clinic near Chicago with a long history of integrative medicine practice, together with the research expertise of the largest cancer institutes in the U.S.

The human mind and body, when confronted with malignancy, reacts with a complex set of physiological and psychological changes that cannot be adequately addressed in isolation. As such, only whole person, multi-interventional synergistic approaches to scientific exploration will lead the way to 21st century personalized, integrative oncology care.

In some ways, whole systems research is still more of a dream than a reality. While many research institutions have experience investigating single integrative interventions, the Block Center is among the few U.S. centers that have experience carrying out whole system therapies in their clinics. To date, very little has been done to practically join research institutes and integrative therapists to implement true, whole systems research. The BIOP aims to change this paradigm.

h3. Why Now?

Integrative oncology has been practiced in multiple clinics around the U.S. and in Europe during the last few decades. While the practices of the clinics differ in details, certain patterns of practice are emerging such as natural food diets, adaptive exercise tailored to the differing phases of cancer care, and the use of mind-body methods for stress reduction based on traditional meditative practices.

At the same time, books have been written that offer the possibility of standardization of integrative practice based on scientific evidence as well as traditional understandings of healing. Specific standards for measuring the impact of integrative treatment on the body can be drawn from this literature.

Further, and perhaps more critical, more patients are now aware of integrative oncology. They know that integrative treatment has the potential to improve their health and cancer outcomes, and, when it is not locally available, are integrating their care on their own, and consulting with a variety of individual practitioners of various complementary therapies.

For the sake of these patients—and all cancer patients in the future—we feel that now is the time to start critically important research to determine the efficacy of integrative regimens for both health improvement and control of disease.

h3. Whole Systems Research—Changing the Research Paradigm

The double-blind, placebo-controlled, randomized controlled trial (RCT) is the gold standard of modern scientific exploration. Traditional clinical trials have been strictly focused on single interventions and single outcomes. This model of science, which is termed reductionistic, has major advantages in the testing of certain types of hypotheses, and has helped lead to the many effective (and less than effective) conventional cancer treatments now available.

Funding agencies are, naturally, reluctant to fund studies outside this paradigm, and a glance at the list of studies funded even by agencies charged with studying complementary and alternative medicine shows that they work on reductionistic models.

However, the emergence of personalized medicine has led to a new understanding of the need to approach the human body as a true, whole system. There is increasing awareness that the advances of reductionistic medicine have overlooked many aspects of the experience of illness and recovery. This has also stimulated interest in multi-interventional, integrative approaches to treatment that address the patient’s recovery from multiple perspectives at the same time.

While randomized trials can be and are used for whole systems research, new approaches are needed to design, collect, and analyze data from such trials: multidisciplinary teams are employed, and models regard patient outcomes from several viewpoints, including an emphasis on patients’ quality of life.

From the Institute of Medicine:

“Integrative health care is derived from lessons integrated across scientific disciplines, and it requires scientific processes that cross domains. The most important influences on health, for individuals and society, are not the factors at play within any single domain—genetics, behavior, social or economic circumstances, physical environment, health care—but the dynamics and synergies across domains. Research tends to examine these influences in isolation, which can distort interpretation of the results and hinder application of results. The most value will come from broader, systems-level approaches and redesign of research strategies and methodologies.”

By combining the resources of the Block Center and the country’s leading teaching cancer institutes, we will create a new platform for developing comprehensive, evidence-based whole systems research.

The IOP aims to approach whole systems, integrative oncology study designs in such a way that they will pass government and private funding review boards as well as research ethics review committees. This will require fresh, innovative thinking and very creative and committed research teams that BIOP leadership will provide. Conventional cancer care is rapidly moving away from a cookie-cutter approach to an individualized, personalized care model based on one’s unique genomic type (i.e., tumor sensitivity testing of tumor tissue at a molecular level, using multi-gene expression assays), targeted therapies, and monoclonal-antibodies. The ascent of integrative cancer therapies as a “whole person, whole system” approach to individualized care for malignant disease follows along this same path by addressing the body, mind, and soul.

h3. The Project Leaders

*Keith I. Block, MD* is the Medical Director and Co-Founder of the Block Center for Integrative Cancer Treatment in Skokie, IL. For over 30 years, the Block Center has been a pioneer in integrative oncology. The Center’s research-based treatment integrates an innovative approach to the best of conventional medicine with scientifically sound complementary therapies—therapeutic nutrition, botanical and phytonutrient supplementation, prescriptive exercise, and systematic mind-body strategies—to enhance the recovery process.

Dr. Block educates medical students in integrative medicine at the University of Illinois at Chicago, and has published research on integrative oncology in several journals. In addition to his clinical position, Dr. Block is the editor of Integrative Cancer Therapies, the first peer-reviewed journal in the field, and is active in the Society for Integrative Oncology. His 2009 book, Life Over Cancer (Bantam Press), sets out the scientific rationale and clinical implementation of his approach to integrative oncology in a way that will make it possible for other centers to carry out the same program with their patients.

*Penny B. Block, PhD*, is the Executive Director and Co-Founder of the Block Center for Integrative Cancer Treatment. She is responsible for the day-to-day implementation of the integrative practitioners at the Center, including psychologists, social workers, registered dietitians, physical therapists, massage therapists, and complementary care specialists. Her research background is in the area of psychosocial approaches to cancer care.

FON Consulting, an integrative oncology research incubator and consulting firm founded by leukemia survivor *Glenn Sabin*, is a co-founder of the project. FON will support the project through ongoing consultation and program development in areas such as fundraising, patient recruitment and advocacy, and research design through provision of the patient perspective.

h3. Scientific Advisory Board

The BIOP Scientific Advisory Board will include internationally recognized scientists in the areas of integrative oncology, whole systems research, nutrition, and statistics. The Board will help the Block and institutional partners’ staff members develop a consistent approach to whole system research in line with the best practices for scientific work in this area.

To be announced

h3. Roles

Research projects funded through BIOP will initially be implemented through studies at the Block Center and institutional partner sites—leading academic-based cancer centers.

* The *Block Center* will contribute long-term experience in counseling cancer patients in lifestyle modification and targeted supplementation.

* Institutional partner will contribute high-level research design and statistical analysis experience, as well as connections to laboratories for sophisticated analyses.

* The *Scientific Advisory Board* will assist in developing designs with a true whole systems focus, assessing outcomes on multiple qualitative and quantitative parameters that holistically address the needs of the patient as a whole person.

As the projects expand and develop, we will begin collaborative projects with other integrative clinical research centers nationally. All projects will involve researchers at both the Block Center and the institutional partner sites, and will be supported by full experimental and statistical protocols.

* For *Block Center* projects, institutional partner researchers will work with Block Center staff to develop sound experimental design and data collection techniques. The institutional partner will likely work with other researchers and statisticians to do the statistical analyses.

* For institutional partner projects, Block Center staff will develop protocols for implementing the Block program at the institutional center’s clinic, and support staff in carrying them out.

h3. Four Initial Projects

BIOP will support several exploratory trials focusing on various populations of malignant disease, starting with the first four projects listed below in order of planned implementation:

*Project 1: Chronic Lymphocytic Leukemia (CLL)*
Few interventions are available for patients with this early stage cancer. Results from a pivotal case report plus studies of natural dietary supplements suggest that a comprehensive lifestyle intervention may offer hope for prolonged remission or disease stability for these patients.

Lifestyle trials have not previously been attempted in CLL patients; an initial proposed study will implement a comprehensive lifestyle system, and monitor patients’ successes and problems in adhering to it. This project will also obtain data on how the lifestyle program impacts some of the basic physiological imbalances that underlie cancer, such as inflammation and insulin resistance. Beginning in 2012.

*Project 2: Breast Cancer Remission*
Trials of diet and some trials of exercise have previously taken place with breast cancer patients, with mixed success. No trials have previously used a full diet, exercise, mind-body medicine, and supplementation approach based on personalized interventions.

This proposed trial will implement such a program with breast cancer patients after their initial treatment. A control group will be placed on a waiting list. Practicality of implementing the lifestyle change, quality of life, fatigue, and impacts on cancer-promoting physiological imbalances will be assessed. Beginning in 2013.

*Project 3: Prostate Cancer Early Recurrence*
Some previous studies have suggested that diet interventions may help slow the progress of prostate cancer. This study will implement a full diet, exercise, mind-body, and supplementation program with a group of prostate cancer patients to determine its practicality and impacts on cancer-promoting physiological imbalances. Beginning in 2014.

*Project 4: Chemotherapy Support Program*
Chemotherapy patients may suffer from side effects that are frequently severe enough to halt treatment. Several lines of evidence suggest that a diet, exercise, and mind-body program may lessen the adverse impacts of chemotherapy, and help patients to complete recommended chemo regimens. The addition of supplements may also help to realign certain cancer-promoting physiological imbalances.

In this study, patients receiving chemotherapy at an integrative clinic in which this full program is implemented will be compared with matched patients at a nearby clinic at which no integrative program is in use. Quality of life, ability to perform daily activities, and ability to complete all recommended chemotherapy dosages will be monitored and compared between the two groups. Imbalances of cancer-promoting physiological processes will also be monitored. Beginning in 2015.

h3. Program Design Highlights

Program designs combine allopathic interventions, exams, and diagnostics featuring biochemical and biomarker lab tests, and an array of innovative, evidence-based integrative oncology modalities.

*Key program highlights include:*

*Changing the body’s internal environment* using diet, exercise, and nutraceutical interventions to remedy imbalances in cancer-promoting physiological processes such as:
* Inflammation
* Oxidation and free radicals
* Stress hormones
* Immune competence
* Insulin and glucose levels

*Focus on anti-angiogenesis* by tapping the powers of fruits, vegetables, and herbal medicines.

*Support through exercise physiology* to strengthen the body’s innate ability to cope with cancer and to energize daily living.

*Mind-body-spirit medicine* to help patients renew their engagement with life and life extension.

*Nutritional pharmacology*, using carefully selected pharma-grade nutraceuticals; herbs and botanicals; and functional foods.

*Achieving anti-cancer nutrition levels* through a plant-based, whole foods diet.

h3. Project Funding

Support for the studies will be sought from three sources: individual donations, corporate donations, and grant applications to charitable and government sources.

The first grant applications are underway with select agencies and organizations that have interests in integrative oncology. Grant applications are being staged with the goal of obtaining funding for one project each year over the next four years, alternating locations at the Block Center and institutional partner site.

Each project will have a target amount based on optimal funding levels needed to hire staff and carry out experimental procedures and statistical analysis.

All grant funds and donations will support investigators at the Block and additional clinical sites according to standard grant budgeting procedures.

*Project-Oriented Giving*

We are initially emphasizing funding for Projects 1 and 2, on leukemia and breast cancer, with a goal to have both of these fully funded by 2012. We will then emphasize funding for Projects 3 and 4, on prostate cancer and chemotherapy support.

Individuals (or corporations) who wish to support research on a specific cancer can do so, even if it is scheduled for later in our projected start dates. If funding for a particular project is obtained earlier than anticipated, there may be an opportunity to move up the projected start date.

After the first four projects are funded, the BIOP will move on to more large-scale collaborations involving more research institutions, based on our experience carrying out the initial pilot projects. Research design summaries and proposed budgets are available for each project.

*Endowment Giving*

Individual donations are encouraged to build an endowment to help pay for the project’s ongoing expenses such as grant-writing, fundraising, budgeting and accounting, board consultation expenses, and travel expenses for developing new projects.

Through the Institute for Integrative Cancer Research and Education, BIOP plans to hire a permanent staff to carry out and expand our goals for whole systems research in integrative oncology. Our initial goal for building an endowment to support a minimal staff is $3,000,000.

h3. Get Involved

The BIOP provides a tremendous opportunity for the Block Center, FON Therapeutics and its institutional partners to effectively lead the way into a new era of medical research.

BIOP is a truly new and pioneering 21st century research paradigm, and welcomes contact from philanthropists, individuals, corporations, private foundations and thought leaders who are interested in supporting innovative, next-generation cancer research.

Contact us today at research [at] or call 301 384 2476.


Get FON: The Business of Integrative Medicine blog delivered FREE to your inbox!