The Challenges of Randomized Trials in Integrative Cancer Care

Abstract

This Point-Counterpoint is the second of 2 articles on the topic of using randomized controlled trials to study integrative cancer therapies. The first, in the previous issue, explored questions on the validity— and wisdom—of proceeding with randomized trials on the great variety of therapies that make up integrative cancer care at this time. In discussing the able responses to that article, an important point was made with regard to randomized studies: for many types of integrative therapies, studies with randomized trials are actually premature. Early-stage phase I–/phase II– type trials are critical precursors to randomized studies of any therapy. Without proper preliminary trials, the design of randomized studies may be inadequate, and the effectiveness of therapies may be missed simply because of defects in experimental design. Such preliminary trials are lacking for many of the therapeutic modes used in integrative care. Thus, before we proceed with randomized trials for many therapies (and for many whole systems of integrative care), it will be necessary to complete some of the earlier stage trials so that we have the data needed to design randomized studies that will truly be able to answer the questions we wish to ask. Nevertheless, there are some therapeutic elements, as well as herbs and supplements, that may indeed be ready for randomized trials. Many of these comprise the individual complementary therapies that play roles in multidisciplinary integrative care. Examples of such therapies include massage, fish oil, art therapy, and others for which preliminary trials have indeed been done. It is the purpose of the present PointCounterpoint to explore more deeply some of the practical questions that arise in the implementation of randomized trials in integrative cancer care. While a number of these questions are probably wellunderstood by investigators already involved in integrative therapy research, they are questions that may plague those who are just starting out in this area. It is our hope that new investigators, and, especially, complementary and alternative medicine (CAM) practitioners who may be contemplating becoming involved in randomized trials, will benefit from the questions explored in this article. We have, again, a distinguished panel of respondents to these questions, whose answers explore topics ranging from the basic ethics of clinical research to how best to make sure CAM practitioners feel comfortable as part of a research team. Drs Andrea Cohen and Adrian Dobs generously rejoin us after contributing to the first Point-Counterpoint in this series. Dr Dean Ornish, who has been using randomized trials to investigate the impacts of integrative systems of care in the cardiac setting for well over a decade, shares with us some of the elements that went into the design of his present trial with a diet and lifestyle modification approach to early-stage prostate cancer. Finally, Dr Debu Tripathy, a member of the Advisory Board of this journal, shares insightful perspectives on both trial design and practical implementation of cancer studies from his career in clinical cancer research, as well as his innovative research in the application of Tibetan traditional medicine in cancer care. Andrea J. Cohen, MD, FRCPC, is an associate professor of medicine at the University of Colorado Health Sciences Center and the director of the Complementary and Alternative Medicine Research Program at the University of Colorado Cancer Center. Her laboratory conducts state-of-the-art clinical, translational, and basic research. Dr Cohen has conducted traditional molecular cancer research including topics in lung cancer on peptides, peptidases, endothelin autocrine loop, and methylation. Dr Cohen’s CAM interests include Indian and Chinese medicine, as well as mind-body medicine. She is Block et al