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National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health, Bethesda, MD
2To whom correspondence should be addressed. E-mail: marich{at}mail.nih.gov
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONUse of complementary and...Mandate to NCCAMNCCAM research of...Upcoming funding for new...LITERATURE CITED |
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KEY WORDS: • alternative • complementary • cancer • research • NCCAM
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONUse of complementary and...Mandate to NCCAMNCCAM research of...Upcoming funding for new...LITERATURE CITED |
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): biologically based treatments, mind-body interventions, manipulative and body-based methods, alternative medical systems and energy therapies. As a center at NIH, NCCAM has independent grant-making authority and increasingly more resources to address the public health challenges and opportunities associated with CAM. Currently, NCCAM funds one or more projects in the area of oncology for each domain. These projects are testing various CAM modalities and cancer conditions. The purpose of this paper is to provide a rationale for the CAM research in oncology, discuss NCCAM research specifically focused on biopharmacologic and herbal therapies for oncology, and describe new initiatives that are pending and in development.
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Use of complementary and alternative medicine for cancer therapies |
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TOPABSTRACTINTRODUCTIONUse of complementary and...Mandate to NCCAMNCCAM research of...Upcoming funding for new...LITERATURE CITED |
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), 50% of breast cancer patients (3
) and 37% of prostate cancer patients use CAM, particularly biopharmacologic and herbal approaches. In four surveys published in 2000, use of herbal therapies ranged from 13% in one survey (3
) to 49% in two surveys of breast cancer patients (4
, 5
), 35% in eight outpatient clinics (6
) and 27% in a pediatric population (2
). Similarly, dietary supplements and antioxidants also are widely used by cancer patients. Supplement use is estimated at 60% among outpatients in a comprehensive cancer center (6
), 26.6% (8.2% megavitamins) among breast cancer patients in four ethnic groups in San Francisco (3
), 49.6% among breast cancer survivors in Canada (5
), 34% of prostate cancer patients in a Veteran’s Administration population (7
) and 41% (high dose vitamins) among prostate patients undergoing radiation therapy (8
). Often, antioxidants are used in combination with conventional oncology treatment.
Recent surveys of cancer patients indicate that disclosure of CAM use to physicians is low (9
). The possible effect of herbals and dietary supplements on the efficacy of conventional treatment, amelioration of side effects or toxicity of conventional treatment, recurrence and survival are as yet unevaluated by compelling, well-controlled studies in preclinical models or cancer patients. As in conventional medicine, the level of evidence for safety and efficacy of CAM ranges from anecdotal reports to encouraging data from small, phase I and II clinical trials to data from larger, randomized clinical trials. The high use of CAM and low disclosure of use to the health care team signal the need for improved monitoring by oncologists if they are to respond appropriately to any atypical clinical responses of these patients (Fig. 1
). Rigorous scientific testing of CAM therapies, however, is of vital importance to inform medical advice and establish clinical practice guidelines for CAM use.
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Mandate to NCCAM |
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TOPABSTRACTINTRODUCTIONUse of complementary and...Mandate to NCCAMNCCAM research of...Upcoming funding for new...LITERATURE CITED |
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The extramural division of NCCAM is charged with increasing the number of NCCAM-supported grants and cofunding CAM-related activities at other NIH institutes and centers. The oncology portfolio at NCCAM is evolving with increasing numbers of meritorious and fundable research applications from the oncology community. As of July 2001, NCCAM was funding 26 research projects in oncology and several trials cosponsored by other NIH institutes. Most of these studies are evaluating biopharmacologic and herbal therapies and almost half are clinical research. The clinical research includes phase I, II and definitive phase III multicenter trials of widely used agents with various endpoints, i.e., survival, disease-free survival, neuroendocrine markers, psychosocial and physical functioning and quality of life.
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NCCAM research of biopharmacologic and herbal therapies |
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TOPABSTRACTINTRODUCTIONUse of complementary and...Mandate to NCCAMNCCAM research of...Upcoming funding for new...LITERATURE CITED |
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To expand the infrastructure for conducting innovative CAM research in oncology, NCCAM also funds specialized research centers at Johns Hopkins University and the University of Pennsylvania. These specialized research centers conduct basic and clinical studies to assess the efficacy, safety and mechanisms of action for CAM therapies for cancer. The Specialized Center of Research in Hyperbaric Oxygen Therapy at the University of Pennsylvania is testing the effect of an emerging specialty of medicine, oxygen at greater than-atmospheric pressures, on head and neck cancer as well as tumor growth and metastasis. The Johns Hopkins Center for Cancer Complementary Medicine is engaged in studies of natural supplements and herbal mixtures. Researchers at Johns Hopkins are testing the antioxidant effects of herbs in cancer cells, antioxidant and anti-inflammatory properties of soy and tart cherry on pain with established animal models and the safety and efficacy of a popular mixture of Chinese herbal medications (PC-SPES) in men with prostate cancer.
The NCCAM oncology portfolio also includes a growing number of investigator-initiated research to evaluate pharmacologic agents and herbals. These projects cover the research continuum from preclinical, mechanism-of-action studies to definitive, randomized placebo-controlled trials. The studies and the institutional site by type of study are listed in Table 1
.
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Upcoming funding for new initiatives |
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TOPABSTRACTINTRODUCTIONUse of complementary and...Mandate to NCCAMNCCAM research of...Upcoming funding for new...LITERATURE CITED |
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NCCAM has agreed to cofund with the National Cancer Institute supplements to five comprehensive cancer centers for CAM research programs. These programs will conduct basic, clinical (prevention, therapeutic and palliative), epidemiologic, population science and cancer control CAM research, including pilot and phase I and II clinical trials. The supplements are expected to be awarded in the fall 2001.
Drug-herb interactions.
Funds will be awarded to meritorious applicants in fall 2001 for investigator-initiated research (i.e., preclinical and phase I and II clinical studies) to study adverse botanical-drug interactions during therapy or anesthesia, establish possible synergistic combinations of botanicals with pharmaceutical drugs and increase our knowledge of the mechanisms of action of botanicals.
CAM therapies at the end-of-life for cancer and human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS).
Funds will be awarded to meritorious applicants in fall 2001 for phase I and II clinical studies of CAM therapies that expand the therapeutic and palliative care options beyond technological and conventional pharmacologic approaches.
Integration of CAM.
Funds will be awarded to meritorious applicants in fall 2001 for health services research that investigates the barriers and facilitators to integration of effective CAM with conventional health care practices; determines whether efficacy studies of CAM (research under ideal conditions) can be translated to effectiveness (real-world settings) in integrated models and evaluates planned or ongoing CAM programs (e.g., outcomes or cost-effectiveness).
Antioxidants and concurrent chemotherapy and radiotherapy.
A workshop is being planned for 2002 to identify the major gaps in our knowledge about use, justification and safety of antioxidants with conventional chemotherapy and radiotherapy.
In conclusion, the NCCAM oncology portfolio is growing, and additional grants will be awarded in fiscal year 2002 in response to several new initiatives as well as investigator-initiated applications. NCCAM funded research and current initiatives as well as an archive of past funding opportunities is available on the website (15
). One primary focus of the current oncology portfolio is biological and herbal agents. Given the widespread use of these CAM approaches by cancer patients and the possibility that their biologic activity may interfere or enhance conventional cancer treatment, such studies are critical. Although some of these agents will show no promise and subsequently will be discarded, others should prove to be beneficial and, it is hoped, be incorporated into interdisciplinary medical treatment. An investment into the research of these therapies is critical if we are to separate the wheat from the chaff and inform patients and the medical community (16
). Information on CAM therapies for cancer is currently available in a searchable database of CAM on PUBMED (17
), summaries of CAM cancer therapies are available on the Physician’s Database Query (18
), fact sheets are available at the NIH Clinical Center website (19
) and protocols of ongoing clinical research are available online (20
).
With continued support from the public, increased funding to maintain the current momentum and participation of the oncology research community and CAM providers, the efficacy and safety of many CAM biological and herbal therapies as well as mechanism for activity will be established.
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FOOTNOTES |
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LITERATURE CITED |
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TOPABSTRACTINTRODUCTIONUse of complementary and...Mandate to NCCAMNCCAM research of...Upcoming funding for new...LITERATURE CITED |
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1. National Center for Complementary and Alternative Medicine. Expanding Horizons of Healthcare: The Five-Year NCCAM Strategic Plan 2001–2005. Available at http://Nccam.Nih.Gov/Nccam/Strategic/. Accessed March 28, 2001. .
2. Kelly, K., Jacobson, J., Kennedy, D., Braudt, S., Mallick, M. & Weiner, M. (2000) Use of unconventional therapies by children with cancer at an urban medical center. J. Pediatr. Hematol. Oncol. 22:412-426.[Medline]
3. Lee, M. M., Lin, S. S., Wrensch, M. R., Adler, S. R. & Eisenberg, D. (2000) Alternative therapies used by women with breast cancer in four ethnic populations. J. Natl. Cancer Inst. 92:42-47.
4. Morris, K., Johnson, N., Horner, L. & Walts, D. (2000) A comparison of complementary therapy use between breast cancer patients and patients with other primary tumor sites. Am. J. Surg. 179:407-411.[Medline]
5. Boon, H., Stewart, M., Kennard, M., Gray, R., Sawka, C., Brown, J., McWilliam, C., Gavin, A., Baron, R., Aaron, D. & Haines-Kamka, T. (2000) Use of complementary/alternative medicine by breast cancer survivors in Ontario: prevalence and perceptions. J. Clin. Oncol. 18:2515-2521.
6. Richardson, M. A., Ramirez, T., Palmer, J. L., Greisinger, A. & Singletary, S. E. (2000) Complementary/alternative medicine use in a comprehensive cancer center and the implications for oncology. J. Clin. Oncol. 18:2505-2514.
7. Lippert, M., McClain, R., Boyd, J. & Theodorescu, D. (1999) Alternative medicine use in patients with localized prostate carcinoma treated with curative intent. Cancer 86:2642-2648.[Medline]
8. Kao, G. & Devine, P. (2000) Use of complementary health practices by prostate carcinoma patients undergoing radiation therapy. Cancer 86:615-619.
9. Richardson, M. & Straus, S. (2002) Complementary and alternative medicine: opportunities and challenges for cancer management and research. Semin. Oncol. (in press). .
10. Kappauf, H., Leykauf-Ammon, D., Bruntsch, U., Horneber, M., Kaiser, G., Buschel, G. & Gallmeir, W. (2000) Use of and attitudes held towards unconventional medicine by patients in a department of internal medicine/oncology and haemetology. Support Care Cancer 8:314-322.[Medline]
11. Verhoef, M. J., Hagen, N., Pelletier, G. & Forsyth, P. (1999) Alternative therapy use in neurologic diseases. Neurology 52:617-622.
12. Burstein, H. J., Gelber, S., Guadagnoli, E. & Weeks, J. C. (1999) Use of alternative medicine by women with early-stage breast cancer. J. Am. Med. Assoc. 340:1773-1739.
13. Sparber, A., Bauer, L., Curt, G., Eisenerg, D., Levin, T., Parks, S., Steinberg, S. & Wooton, J. (2000) Use of complementary medicine by adult patients participating in cancer clinical trials. Oncol. Nurs. Forum 27:623-630.[Medline]
14. Adler, S. R. & Foskett, J. R. (1999) Disclosing complementary and alternative medicine use in the medical encounter: a qualitative study in women with breast cancer. J. Fam. Pract. 48:453-458.[Medline]
15. National Center for Complementary and Alternative Medicine. Website. Available at http://nccam.nih.gov. Accessed July 28, 2001. .
16. Voelker, R. (2001) CAM research attempts to separate wheat from chaff. J. Am. Med. Assoc. 286:156-158.
17. NCCAM on PubMed. Available at http://www.nlm.nih.gov/nccam/camonpubmed.html. Accessed July 28, 2001. .
18. CancerNet. Available at http://cancernet.nci.nih.gov/index.html. Accessed July 28, 2001. .
19. NIH Clinical Center. Facts about dietary supplements. Available at http://www.cc.nih.gov/ccc/supplements/intro.html. Accessed July 28, 2001. .
20. Clinical trials. Available at http://www.clinicaltrials.gov. Accessed July 28, 2001. .
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