The Annie Appleseed Project invites you (and your organization) to join in our campaign for clinical trials on The Patient Track. The Patient Track represents the idea of clinical trials yielding information of immediate value to the patient population. JUSTIFICATION: Many studies have shown that cancer patients are using complementary/alternative (CAM) therapies. Just in the last two years, there have been studies by Metz, 2000, Richardson, 2000, Kelly et al, 2000, Damkier et al, 2001. These researchers have found, as many before them, that up to 80% of us are doing something that can be called CAM. David Eisenberg at Harvard is credited with one of the earliest surveys of this kind, but they have been done at many hospitals, institutions and other locations. At the same time, these studies also demonstrate that few patients actually discuss their complete programs with their healthcare providers. This should be of great concern to all of us. The Project states, on the front page of our website, that patients MUST talk to their doctors and other providers about everything that they take or do. After all, if it is meant to work, it may have implications vis other treatments. But what exactly are those implications? Does anyone really know? PROPOSED CLINICAL TRIAL: The Annie Appleseed Project therefore has begun a call for randomized, (double-masked)*, multi-center clinical trials of what patients actually take. (*Kay Dickerson, Ph.D., a researcher and advocate whom I admire has suggested that double-blind is really not an appropriate term to use). Our first proposed trial would have one arm for patients using the standard chemotherapy regimen, with another arm for patients combining the chemotherapy with a panel of antioxidant vitamins (E, C, A, selenium, D, EPA/DHA, possibly others to be determined) The Project would prefer to see a third arm for those patients who having chosen NOT to take chemotherapy, would be willing to use vitamins alone. Each of these substances has been examined separately and indicated efficacy against cancer cells in vitro, in animal models and sometimes, even small human studies. A study reference list is attached which cites a number of studies that have had positive results using vitamins against cancer. POSSIBLE RESULTS: Patients using vitamin therapy along with conventional chemotherapy might have less adverse effects. There could be enhanced ability to tolerate the chemotherapeutic regimen (many patients cannot complete their course of therapy due to toxicity). Patients in that arm might fare better in some as-yet-unknown ways. OR: All the above could NOT happen. It might be discovered that this set of patients fare worse in a variety of measurable ways than the patients solely using conventional chemotherapy. The point is, we would KNOW. WHO WOULD BENEFIT: 1) patients would benefit by KNOWING if there was a value in using a panel of vitamins during conventional chemotherapy. 2) If there was no value in this, patients would be able to save their money and time to concentrate on other strategies. 3) Pharmaceutical manufacturers might discover that more patients have less adverse effects and better able to tolerate chemotherapy. 4) Companies that manufacture vitamins would benefit if it could be shown that there was a value in using them in conjunction with conventional therapies. 5) Oncologists and other providers would benefit by KNOWING what to say to patients who ask questions about vitamin use. 6) FDA, NCI and other agencies would benefit by having a jump-step on some new trial designs. This is a WIN=WIN situation. And the information would be of IMMEDIATE value to all of the above mentioned ‘stakeholders’. We urge you to sign onto the campaign for The Patient Track. Abstract style proposals will be sent to the major ‘stakeholders’. The Annie Appleseed Project is planning meetings with pharmaceutical companies, clinical trial cooperative groups, clinical trial associates, ‘trade’ organizations, patient/advocacy groups, hospitals, institutions, research funders and, government agencies. Please indicate by return email, perhaps you yourself are currently using supplements without talking to your healthcare provider. We are at the earliest stages of strategizing how to move forward and welcome your input. We would like to form a committee or group to oversee this particular plan. annieappleseedpr@aol.com Plus see the studies in the Relevant Studies section 3/6/02 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.