Together We Can -- Newsletter of the Joan Karnell Cancer Center

Winter 2002

Are Clinical Trials For You?
Nutrition & You: The Importance of Food Safety
New Cancer Resources
News Anchor Works to Increase Breast Cancer Awareness
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Are Clinical Trials for You?

According to the American Cancer Society, about 1,284,900 new cancer cases will be diagnosed this year. If you are one of these patients, you should be aware of the various treatment options available to you – including clinical trials. At the Joan Karnell Cancer Center at Pennsylvania Hospital, patients can participate in national clinical trials, which offer the opportunity to receive new, and potentially more effective, treatment options.

Surprisingly, 85 percent of cancer patients are not aware that participation in a clinical trial may be a treatment option, according to the Coalition of National Cancer Cooperative Groups, a national network of cancer clinical trial specialists. “My work includes helping to identify patients who may be eligible to participate in a clinical trial,” says Holly Kilpatrick, RN, one of many clinical research nurses at the Joan Karnell Cancer Center.

“We have more than 60 protocols currently available. The majority of the studies are government funded while others are funded by pharmaceutical companies.” Many of these trials are available to us through our membership in the University of Pennsylvania Cancer Network.

What is a Clinical Trial?
Before the Food and Drug Administration (FDA) can approve a new drug or treatment protocol, it must undergo three phases of clinical trials. The first phase begins after extensive laboratory research, trials on animals and the filing of an Investigational New Drug application with the FDA. Phase I trials are performed on small, select groups of patients to determine the correct dosage and evaluate any possible side effects.

Phase II trials, which generally involve fewer than 100 participants, are used to determine if the new treatment actually has a positive effect against cancer. In general, according to the Coalition of National Cancer Cooperative Groups, if at least 20 percent of patients respond to the treatment, the new protocol moves on to Phase III.

It is during Phase III that most patients would become involved in a clinical trial. Here, a large group of participants is needed to determine how the new drug or protocol compares to the best existing treatment currently available.

What to Expect
“It’s important that patients realize that by participating in a clinical trial they are not guinea pigs. Actually, they are offered the best possible care that is currently available — and perhaps even the best possible treatments options for the future,” says Kilpatrick. “During the trial, participants are assigned a specific research nurse who can help answer questions and provide close, personal follow-up care for their conditions.”

Some patients may also be concerned about receiving placebos but in those clinical trials where placebos are used (and not all trials use them), patients still receive standard care. In other words, by not receiving the drug being tested, the patient is not missing part of his or her treatment.“ The patient would always get the best care that’s available,” says Kilpatrick.

Your Commitment
What’s involved in committing to a clinical trial? In terms of cost, most treatment is usually considered standard by medical insurers and is often covered. In many cases, for those treatments not covered, the study will provide the funding to have patients treated. Even patients without insurance may be able to participate in a clinical trial, assuming they are eligible for the study.

Time is of the essence to everyone and, as a result, some patients may reject the idea of participation in a clinical study due to time commitments. In fact, although the length of time a clinical trial can vary is anywhere from a few months to several years, the amount of time a patient needs to devote to check-ups and appointments is generally not that much more than what is required for typical physician visits.

Before committing to a clinical trial, be sure to read the information provided and make sure you understand it. Write down any questions you may have and discuss these with your doctor. A clinical trial is not the only treatment option available to you but it may be one of the best. Be sure you understand the potential benefits and risks before you commit.

“It’s also important to realize that you’re not just gaining access to the best possible care for yourself,” says Kilpatrick. “You may actually be helping thousands of others afflicted with cancer. People might one day receive a new drug or treatment protocol because of your participation in the trial.”

For more information on clinical trials at the Joan Karnell Cancer Center, call 1-800-789-PENN (7366).


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