Well, what do you know? I recently moderated a workshop for seven cancer patients diagnosed within the past six months, along with their primary support persons. And the subject of clinical trials came up. Now, I cover the difference between standard treatments and clinical trials in My Notebook, in the section called “Getting Treatment: The Basics of Cancer Care, Standard Treatment vs. Clinical Trials.” Still, it seemed to me that everyone wanted a lot more discussion on the topic. So, it is now the subject of my next blog.
There were three people in the workshop who had just been diagnosed, and were still looking at what their treatment options might be, once their differential diagnoses were completed. Two more were diagnosed less than three months ago, with very serious stage 3 and 4 cancers. Two more participants were diagnosed four months ago, had undergone surgery, and were already in a standard treatment.
And all the participants were still fuzzy on the idea of clinical trials, and wanted to know if they should be considering them. In fact, depending on the type and site of the cancer, and where they were willing to go for treatment, any one of them might be a candidate for participating in a clinical trial. I asked, and none of them had been told that, for their cancer, there was a standard treatment available to them that worked extremely well in other patients who shared the same characteristics as themselves (for example, age, gender, race). That, there, is a good enough reason for me, if I were in their place, to want to check out other treatment options. They all agreed they would like to check further into clinical trials. They wanted more basic information on why and how to go about it.
So, first, here are the basic reasons why you might want to consider becoming a participant in a clinical trial. If you:
- Have a cancer for which there is currently no standard treatment that has been shown to be routinely effective in reducing or curing your cancer.
- Have a cancer for which the standard treatment has been effective in some patients, but not shown to be effective for many others
- Are diagnosed with a later stage disease or were treated for your cancer, but it recurred later
- Have a cancer for which the standard treatment has been effective, but for which the research doctors are looking for new ways to reduce the side effects or to find new approaches that work better than standard treatment
- Want to consider a treatment that will take less time, cost less, or need less radical surgery or high doses, but still have the same or better outcome.
Clinical trials are basically studies funded by the government, by other cancer foundations, and by pharmaceutical and medical devices companies who are developing new cancer-fighting treatments and techniques. For a more complete discussion on how clinical trials are conducted, look through My Notebook’s section on clinical trials, where it discusses the difference between Phase I, II, III and IV clinical trials.
The results of clinical trial studies, called “treatment outcomes” may include better methods for eliminating your cancer tumor or cancer cells, shrinking the tumor’s size, stopping the cancer cells from multiplying, keeping your cancer from spreading, and/or keeping it from coming back. Or, the outcomes may focus on easing your post-treatment nausea, avoiding side effects such as hair loss, bolstering your system’s defense against infection or other secondary illnesses, or managing your pain. These second set of treatment outcomes may be of benefit to you, even if you have already begun a standard course of treatment.
Two important misconceptions: (1) The patients who are being treated in clinical trials studies are not human “guinea pigs.” The laboratory animal testing of these treatments has been exhaustive before the treatment research has progressed into clinical trial studies. (2) If you participate in a drug treatment study, you will not be given a “sugar pill,” or placebo, instead of a cancer treatment drug. You will either be given the new treatment(s) that are the subject of the study, or you will receive the standard treatment(s).
For your specific disease, there may be no current clinical trials; there may be one or two; there may be many. There may be trials going on for your disease, but they could be in another part of the country (so you would have to decide if you would be willing to consider going there for treatment), or they could only include patients of a certain age or sex or some other “eligibility” requirement that would exclude you from participating in the trial. For some clinical trials, you may not be able to receive these new research treatments if you have already been given an older, standard treatment, so it may be very important to find out what clinical trials may be available, before you and your doctor decide on an initial course of treatment.
Understand that it is possible that your doctor just doesn’t know about any, or all, of the experimental trials for your type of cancer, or may have a bias against clinical trials, or may tell you that they are too expensive and mostly not covered by insurance. Check them out anyway. You, with or without your doctor, can look up which oncology doctors are conducting clinical trials for your specific disease in PDQ, a database of standard and clinical trials treatments, developed by the National Cancer Institute. It is updated monthly with the latest listings of clinical trials and their criteria for eligibility. It is an extensive list, although it excludes many drug company trials, funded by the drug companies alone, without NCI funding. Interactive, online listings and descriptions of PDQ trials and preliminary results can be reviewed on the PDQ website, http://www.cancer.gov/publications/pdq. To get current information on drug company-sponsored trials, go to the Internet site, http://www.CenterWatch.com. Drug companies often bear the costs associated with their trial treatments, and sometimes even pay patients for their participation.
If you are going to consider a clinical trial, and there is a trial that is studying your type or site or stage of cancer disease, you will need to meet the trial’s “eligibility criteria.” These are strict entrance rules for participating. You may not “qualify” for a study, even if the researchers are studying your cancer disease. The reason might be because you are not within the age range they are studying, or because you are male and they are only studying females, or because you are of child-bearing age, or because you have had or are having medications or treatments that would interfere with, or be confused by, the results they are trying to achieve in this individual study. These eligibility requirements are developed at the time the research study is designed, for two purposes: first, to protect the volunteer patients from any undue risk, and second, to make the results of the research more reliable.
The bottom line on eligibility requirements is this: If you don’t qualify, don’t take it to mean that you aren’t treatable. You may be eligible for another clinical trial studying your type of cancer, either now or a later time.
If you have been checking out the option of participating in a clinical trial, and would like to discuss your findings, I would be happy to hear about it.