Clinical Trials: Helping Future Cancer Patients Today

Article Date: Nov 13, 2013

Celeste Ellis

Alegent Creighton Health offers more clinical trials to more patients than any other health system in the area. Our trials are mainly large trials, initiated by national cancer centers. And our research is translational—directly impacting bedside care.

Two weeks before her sister died from breast cancer, Celeste Ellis found a lump of her own. It never occurred to her that she too had breast cancer.

"I thought it was a plugged duct or an infection of some kind," she said. All her attention was on her sister, who was diagnosed in 2000, lived cancer-free for nine years, then had breast cancer a second time. She lived two years after that.

The Friday after her sister's funeral Ellis had a mammogram at the Alegent Creighton Health Lakeside Breast Health Center. She was called back for a biopsy. "I knew then," she said. The cancer was six centimeters, or about the size of a ping pong ball, and she was Stage 3. "The worst call I ever had to make was to my mother. She was still reeling from losing her other daughter."

Since then, Ellis has had a bilateral mastectomy, calling it a necessary "no-brainer" and she's undergone chemotherapy and radiation. She was determined to help others, so she became one of hundreds of Alegent Creighton Health patients involved in clinical trials. In fact, Alegent Creighton Health has up to 60 clinical trials going on at any time and they run the spectrum of cancers.

Gamini Soori, M.D., is medical director of Alegent Creighton Health's Bergan Mercy Cancer Center. He said patient participation is voluntary and physicians involved in the clinical trials give their time because they want the best for their patients. "Clinical trials often represent the best and newest cutting edge care available. It pleases us that we can offer our patients that advantage," he said.

A new medical breakthrough can come almost every day through clinical trials, moving cancer prevention or treatment forward. "Cancer is going to affect all our families," Dr. Soori said. Ellis had already lost a great aunt and her sister to breast cancer and had "no qualms whatsoever" enrolling in two different trials—one during treatment, a second one after.

"My life occupation is to serve others," said Ellis, who is mission director at her church. When she organized a Bible Study group, she was astonished to find a 13-year breast cancer survivor, a clinical cosmetologist who works with breast cancer patients, a patient who was newly-diagnosed and the woman who had chemotherapy next to Ellis' sister in her group. "God places people in your life for a reason," she said.

"Ultimately you have to pay it forward," she said about her study group and the clinical trials. "I want to help someone else so they don't go through what I've gone through. The drugs I'm on—someone else was involved in a clinical trial for them."

The Missouri Valley Cancer Consortium provides Alegent Creighton Health and patients like Ellis access to hundreds of cancer-related studies throughout the country, including protocols conducted under the direction of the National Cancer Institute. The clinical trials are focused on treatments, prevention, controlling symptoms and how care is delivered to the community and whether there are barriers to accessing care.

Nationally, two percent of cancer patients are enrolled in clinical trials. At Alegent Creighton Health, enrollment is seven percent. Dr. Soori said those who participate receive the current proven standard of care and also have the option to participate in a trial that could potentially advance the standard of care. Patients have access to new medicines and other benefits, such as no- and low-cost drugs and treatments. "In clinical trials, the expectation and the hope is that the new treatment will be better than the existing standard of care," he said.

Dr. Soori was disappointed at the low participation nationally. "Wouldn't it be a better world for us if we could take that two percent up to four percent?" He said many hesitate because they're already emotionally and psychologically overwhelmed and the trials add another layer of concern. "They perceive it as a scientific experiment. They don't want to be a guinea pig." But he said a lot of safeguards are built in to protect the patients' rights and welfare and results are monitored continuously. "We look at safety concerns and anything that could be an issue with the trial. We have the option of pulling the plug."

Many times, he said, the clinical trial actually provides a better treatment. Dr. Soori said Alegent Creighton Health has been involved in some groundbreaking trials. He's most proud of one that looked at the drug Herceptin . Working with the Mayo Clinic, Alegent Creighton Health physicians and patients tested it to see if it could potentially reduce hot flashes among breast cancer patients. The drug was found to work—patients experienced a 47 percent improvement while using the drug. Of the 3,000 patients who enrolled across the country, an impressive number were Alegent Creighton Health patients."We helped set the standard of care for the world."

Another dramatic finding that came out of a clinical trial here was that six months of chemotherapy for colon cancer is just as effective as a 12-month regimen.

A trial can be as short as six weeks, with results known within a year or two. Others take much longer. Dr. Soori said even after a trial is completed, "The data has to mature. We have to see. We won't know for five years if the patient is cured." The findings are presented at a national conference, critiqued and published in peer review journals. Finally there's a widespread adoption of the results.

To Dr. Soori, clinical trials are a must for making tomorrow's care even better:  "If we keep doing the same thing, we're not keeping our obligation to future generations."

Ellis felt the same way. "It isn't about you. It's about giving someone else peace of mind." Since her surgery, chemo and radiation, she's had reconstruction. She not only participated in clinical trials, she relied on other services Alegent Creighton Health provides. Her nurse navigator visited with her every time she underwent chemotherapy and made sure all her questions were answered. "She connected all the dots for you on everything." Alegent Creighton Health provided the family with financial assistance. And clinical cosmetologists at the Image Recovery Center helped shave her head when her hair started falling out and showed her how to use wigs, scarves and prostheses. "They helped me feel as normal as possible!" At the Lakeside Breast Health Center she found RN-Nurse Practitioner Patti Higginbotham and Radiologist Katie Mendlick, M.D., invaluable. "They were extra compassionate. They were meant to do their jobs."

She said she has "no evidence of the disease" today, instead of saying she's cancer-free. "I'm doing everything I can to keep it from coming back." That included reaching out to her friends at Alegent Creighton Health, who helped keep her spirits up. "They know and I know attitude is everything. You have to stay focused and you have to stay positive."

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