When existing breast cancer treatment methods don't offer as much hope as you'd like, the next thing to think about may be a clinical trial. This can be the best way to get access to new treatment options that aren't available otherwise. However, joining a clinical trial comes with its own share of discomforts and risks -- and depending on how the trial is structured, it can seem like a shot in the dark.
Still, it's a good idea to be informed about clinical trials. Here's how to start exploring the advantages and risks:
What's a clinical trial?
Drug companies, doctors, and medical researchers use clinical trials to test the effectiveness of new drugs, medical devices, and treatment methods. Clinical trials can also be used to compare different treatment methods and see which is more effective. Sometimes a drug or treatment that has already been tested and approved for one condition or group of patients is given an additional trial to see if it works for another condition or group. For example, a drug that works for prostate cancer might be tested to see if it also works for breast cancer.
Getting into a clinical trial is often the only way to try new drugs and treatment methods that haven't yet been approved by the Food and Drug Administration (FDA), the branch of the government that screens new medications for safety. However, because drugs and treatments in trials are still experimental, there may be unknown safety risks.
Clinical trials are necessary to ensure that effective new treatments eventually find their way to patients -- the drugs and treatments currently available all went through clinical trials. The testing process for new drugs and treatments is rigorous, requiring multiple steps so that researchers have plenty of chances to spot side effects and monitor risks. Clinical trials are conducted in four separate phases to ensure safety.
What does it mean if the study is "blind"?
A blind study is one in which patients are randomly assigned into two groups, one of which receives the new drug or treatment being tested, while the other receives standard treatment. In some blind studies (though never in breast cancer studies), the new drug is compared to a placebo, which is an inactive pill that looks just like the drug being tested.
These clinical trials are called "blind" because patients don't know which group they're in. A double-blind study is one in which neither the participants nor the researchers know which group is receiving which treatment. Placebos aren't used when researching treatment for breast cancer or other serious diseases because they are never used in cases where not receiving treatment would endanger the participants in a trial.
To get in a clinical trial, is it necessary to change doctors?
That depends. In some cases, your oncologist may recommend or support joining a clinical trial, and may be able to work closely with the team conducting the trial and continue to oversee treatment. In other cases, enrolling in a clinical trial may require going to another medical facility -- even one outside the area o r out of state -- and accept the supervision of a new medical team.
Does a clinical trial offer better care?
That's quite possible, but it depends on the particular clinical trial, and also on the level of care you -- or the person you're caring for -- is currently receiving. Typically, participation in a clinical trial requires very close monitoring, including lots of tests and personal attention from researchers who may be top specialists in their field.
On the other hand, researchers in a trial are naturally focused closely on the effects of the drug or method they're testing. They may not be as focused on monitoring patients' overall hea lth and well-being, coordinating other treatments, and offering help in dealing with side effects and lifestyle issues.
Does participating in a clinical trial pose extra risk?
By definition, a clinical trial is trying something new that hasn't been fully tested, so, yes, there are risks due to possible side effects, drug interactions, or other symptoms that the researchers don't yet know about. Of course, researchers want the drug or method to be safe and to protect patients from harm, so you can be sure they have patients' interests at heart. And if it's a phase III trial, which is most common, the treatment has already been tested in previous trials. Still, entering a clinical trial does pose additional risks that you should be sure to understand fully.
Do clinical trials require anything special from patients or families?
Clinical trials are conducted by a research team that usually includes doctors, nurses, social workers, dietitians, and other health professionals. The te am will give you -- or your family member -- specific instructions to follow, which may include keeping logs or filling out questionnaires. Also, the research team may need to stay in contact after the trial ends.
Will insurance cover a clinical trial?
The answer isn't simple, and it depends on the type of insurance, the state you live in, and many other factors. Typically, the organization sponsoring the clinical trial covers what are considered the "research costs," which include everything associated with the running of the trial: data collection and management, the time spent by the research physician and nursing staff, and the tests performed as part of the trial. There is, however, a whole set of additional costs known as "patient care costs," which usually include transportation to and from the trial, as well as blood tests and other tests not directly related to the trial. The sponsoring organization often doesn't cover these.
There's good news, though: At the urging of the National Cancer Institute, a growing number of states have passed legislation requiring health plans to pay the cost of routine medical care that patients receive while participating in a clinical trial.
This doesn't mean, however, that insurance pays all the costs. Clinical trials often involve additional tests, medications, and medical appointments that don't fall into any of these categories. Some health insurers and managed care prov iders will decide if they'll cover patient care costs based on whether they consider the trial treatment to be "experimental" or "investigational" -- in which case they'll say no -- or "established" -- in which case they may cover it. Disputes often must be negotiated between the research sponsor and the insurance company.
Medicare does reimburse patient care costs for its members who participate in a clinical trial to diagnose or treat cancer. Information about Medicare coverage of clinical trials is available at www.medicare.gov (click on the Search Tool called "Find Out What Medicare Covers" and, on the next screen, choose the coverage topics "Clinical Trials" for inpatients, outpatients, or both).
How do I find a clinical trial for breast cancer treatment?
The first step in finding a clinical trial is to speak with your doctor about what types of new treatments are being studied and what might work best for you or the person in your care. Let the doctor know that you'd like to consider a clinical trial, and discuss the possible approaches. There may be several options to consider, or there may be one specific treatment your doctor recommends.
Surprisingly, though, many breast cancer patients and their families find that their oncologists aren't the best source of information about clinical trials. A national survey of cancer patients found that eight out of ten cancer patients were unaware of the existence of clinical trials, and that doctors reported being unable to help their patients enroll because they don't have the time, staff, or funding to keep up with the vast number of trials happening across the country. The best way to find out about clinical trials is to research them yourself. To do so, see Clinical Trials for Breast Cancer Treatment: A Step-by-Step Guide .