Senior used trial to focus on getting well

Henry Tyler wasn’t scared when he agreed to participate in a one-year clinical trial at Eastern Maine Medical Center’s CancerCare of Maine. Diagnosed with leukemia, he put his focus on getting well. If the clinical trial could give him a better shot at doing just that, then he was all for it. Good call. Today his cancer is in “micro-remission” and he is healthy.

“I wasn’t nervous,” said Tyler. “Once you hear the cancer diagnosis, your life changes. And I was monitored so closely during the trial that if any adverse reaction was going to happen, I knew it would be handled immediately.”

According to the National Cancer Institute, “Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose or treat cancer.”

There are several types of clinical trials: treatment, prevention, screening and quality of life, each with its own set of questions that scientists hope to answer.

Eligibility requirements must be met to enter a trial, and vary depending on the type of study.

“For each trial, certain characteristics must be present in all participants,” said nurse Ambie Hayes-Crosby, clinical research manager for CancerCare of Maine.

“It is important to understand that cancer trial participants must be screened to be sure they meet the necessary guidelines. The doctors and the nurses involved in the study have to be sure they fully inform each potential enrollee of any potential risks,” she added.

When drugs are tested, the Food and Drug Administration must monitor the trials closely to ensure the safety of the participants.

“We are held to the strictest scientific and ethical principals,” said Hayes-Crosby. “Each trial has a plan attached that is carefully described and scrutinized by experts. A clinical trial that is sponsored by a company testing a new drug or a new combination of drugs must be evaluated by the FDA for patient safety, and safeguards put in place to monitor the patient’s health. Ensuring safety is an important component. Patients participating in a clinical trial can rest assured that their welfare is of utmost concern.”

Before participating, the enrollee must sign an informed consent form which describes the trial, its goals and possible outcomes and occurrences in detail. As always, the decision to enter a trial should be made only after carefully discussing the informed consent with the person’s physician.

“People who may be considering entering a clinical trial can take comfort in knowing that they will receive the absolute best in medical care and will be watched very closely,” said Tyler. “I always felt that I was in very good hands.”

“Everyone with a cancer diagnosis should at least let the idea of a clinical trial permeate the mind,” said Tyler. “There have been several recent breakthroughs in cancer drugs for cancers once considered untreatable because of clinical trials.”

“Even if someone is given a cancer diagnosis and is told there is only a minimal chance of recovery, he or she may still be eligible for a clinical trial,” said Dr. Janet Hock, director of the Maine Institute for Human Genetics and Health.

“The best outcome is when data from a clinical trial show that patients lived longer or have a better quality of life,” she said. “At the very least data from clinical trials provide information to the scientists, which will lead to better decisions on diagnosis and care for the next generation of patients.”

And that’s quite a legacy to leave.

For more information on cancer clinical trials at EMMC, call CancerCare of Maine at 973-4249.

Carol Higgins is director of communications at Eastern Agency on Aging. For more information on EAA, call 942-2865, toll-free (800) 432-7812, e-mail info@eaaa.org, or visit www.eaaa.org. TTY 992-0150.