By Shauna Shepler

On Halloween, Gary Rhodes gathered with his three granddaughters at his home in Bloomdale, Ohio, to shave Grandma Sandy's head. But this was no prank. Sandra, who worked 35 years (her entire adult life) as a beautician making other women's hair look beautiful, has been losing hers due to chemo.

"One of my granddaughters said to me, 'Grandma, you look like Britney Spears'", laughs Sandra, 59. "You know how some say people who've been married a long time start to look like each other after awhile?" she continues. "Well, the difference between him and me is his hair will never grow back, but mine will. We're going to have some hilarious Christmas photos this year," she says laughing. This past July, Sandra was diagnosed with hormone receptive breast cancer.

In September, Sandra met with an oncologist at Blanchard Valley Hospital in Findlay, who told her she would be a good candidate for a clinical trial the hospital was performing to test the odds of recurrence in women with breast cancer. According to Miki McClain, RN, of the Oncology Clinical Research Department, Sandra's trial involves taking a specimen of her tumor and having genetic testing performed on it to determine the chances of her cancer recurring. A low chance of recurrence would allow her to receive a hormone deprivation pill without chemo, but a high chance of recurrence would mean chemo in addition to the HD treatment. "This study isn't about medication, it's about the genetic testing that can keep women who wouldn't benefit from chemo from having to receive it," says McClain.

Sandra felt apprehensive about participating in a clinical trial at first. "I wondered, 'Was this study experimental? What would it entail? And, would my insurance cover it?," she says. In the end, Sandra decided to participate in the study to help and offer hope to others like her.

McClain contacted Sandra, and she got on the study in October. The chance of her breast cancer recurring was found to be eight percent. That may seem like a small number to most, but it was too high for Sandra, so, she decided to take chemo along with her HD treatment.

In cancer research, a clinical trial is a research study wherein the goals are to answer specific questions about cancer, find better ways to prevent or detect it, and find better ways to treat or improve patient care. Clinical trials compare standard treatments (those that have already been proven in previous trials to be effective) to new treatments.

McClain says BVH offers more than 100 clinical trials sponsored by the National Cancer Institute (NCI). There are different types of trials available for first line (first chemo) treatment and second line (second chemo if first doesn't work, or their  disease has progressed) treatment, and each trial is categorized into four groups: treatment, prevention, supportive care/quality of life, and screening/diagnostic trials. Treatment trials explore new approaches to treating cancer and try to determine which approach would be most effective in treating certain types of cancer. Prevention trials, which are conducted with people who have not been diagnosed with cancer, or have had cancer in the past, look at ways to reduce their risk of getting the disease, or a recurrence of it. Supportive care/quality of life trials focus on alleviating the side effects associated with cancer treatments and cancer itself. Screening/diagnostic trials look at better ways to detect and diagnose cancer. Their focus is on earlier detection and accurate staging in hopes of increasing a patient's chance of survival.

"Unfortunately, most people don't realize that we have a research program here locally," says McClain. The Oncology Clinical Research Department at BVH works closely with the Clinical Oncology Program in Dayton, Ohio. This allows BVH to provide quality research trials in a more convenient location; whereas, patients used to have to travel to Columbus or Cleveland in the past.

There are many positive aspects to participating in a clinical trial, McClain says "First of all," she points out, "advances in the way we treat cancer are made possible by patient participation. Clinical trials provide patients access to promising new treatments that might not be available elsewhere. At the same time, results from these studies are used to benefit others in the future. And, another benefit to being part of a study is the fact that our office staff is always available to patients as an additional resource."

Perhaps another benefit to participating in a clinical trial is that most insurance plans will cover their portion of the cost, and in most cases, any drugs and/or genetic tests that a patient would need are provided by the study. Uninsured patients are also eligible for clinical trials. In fact, "in some cases (participating in a clinical trial) is beneficial to them, since some of the drugs are provided," says McClain.

McClain says most patients are surprised to learn that a small hospital like BVH even has a clinical research program. "But after the surprise goes away and we have had a chance to explain the particular study," she says, "the majority are excited about the opportunity (to participate)." "The great thing about being treated at a smaller community hospital like BVH," she continues, "is that we are first and foremost concerned with what's best for the patient. The words, 'research study' sometimes make people a little uneasy at first, but the days of people being used as guinea pigs is long gone" and each patients is given a detailed consent form outlining every aspect of the study before they are allowed to participate.

Not all new cancer patients are reviewed for eligibility to participate in a clinical trial, McClain says, but the hospital's goal is to enroll at least four percent of new cases each year. "This may not seem like a very large number," she says, "but there is a tremendous amount of time, effort and paperwork involved with each patient, as well as the follow-up work that continues to be done on past patients."

Each type of clinical trial has specific eligibility requirements, depending on the patient's type and stage of cancer. But in general, patients must be at least 18 to participate in a clinical trial at BVH.
Additionally, he/she cannot have any other chronic illnesses such as heart problems, stroke, kidney failure, etc. This is to ensure the patient's safety, and, according to McClain, "If a person were already severely sick from another cause, it would distort the results of the study."

Patients are closely monitored during their clinical trial not only by McClain and Clinical Research Associate Denise Shepler, but also by the Dayton COP. Patients like Sandra are monitored by the research department for five years to life once their treatment ends. They have the right to stop participating in their study at any time, says McClain. Additionally, they may get on another trial if there is one available that they are eligible for.

For Sandra, one of the hardest parts about having cancer is being confined to her home and the hospital, and not being able to work. This winter, the mother of two hopes to be well enough to vacation in Florida with Gary, her husband of 40 years. And someday, she would like to go back to substitute teaching at Elmwood High School, which she had been doing since retiring from her job as a beautician in 2001. "I really miss the kids," she says.

For now, her focus is on survival. "Having cancer has made me realize that it could all be over just like that, but I intend to live until the very end," she says, fighting back tears. "My patience may not be all there, but my peace is." And so is her humor.

To learn more about clinical trials, contact Miki McClain at (419) 423-5428.