ETHEL to the Rescue

How ETHEL helped researchers unmask an ineffective treatment used worldwide.

By Chris Pennington; Photo by Peter Barta

Hannah Duckworth hangs onto things that matter.

Part of her collection from the time she received treatment at St. Jude Children’s Research Hospital is a little green bracelet, emblazoned with a line drawing of a woman named Ethel. The bracelet is cheap, but its significance is invaluable. It’s the reminder of a clinical trial in which Duckworth participated.

“My memory of that time is patchy,” Duckworth says of her treatment for acute myeloid leukemia seven years ago. “But I do know that any time someone offered a study, I wanted to help out where I could.”

Duckworth is one of about 90 patients who participated in the first study of its kind, to find out whether a treatment commonly used around the world is actually effective.

Lifeline for patients

Most children undergoing cancer treatment have central venous catheters, known as central lines, surgically inserted into their chests. Connected to the bloodstream, the central line allows clinicians to draw blood and deliver fluids and medicines without repeated needle sticks.

Although they’re lifesaving, central lines can also cause problems. About a fourth of cancer patients develop central-line infections during therapy; this is caused by bacteria or other germs building up in the line and spreading to the bloodstream. These infections require hospitalization and delay cancer treatments. In some cases, the infections require surgical removal of the central line or can even be life threatening.

“I got an infection in my lung and line,” Duckworth says. “It was a wild trip and an extremely brutal treatment.”

A difficult sell

Many hospitals use ethanol, a type of alcohol, to prevent or treat central-line infections. In ethanol-lock therapy, an ethanol solution is placed into the central line to kill bacteria.

In the lab, ethanol effectively kills bacteria in central lines. But is the treatment effective in humans?

That’s what Josh Wolf, MD, of the St. Jude Infectious Diseases Department, wanted to know. He and his colleagues teamed up with clinicians in Australia to find the answer.

As part of a clinical trial, patients were randomly assigned to a six-month schedule of central line treatment. Half were treated with ethanol therapy and half with the normal heparin-saline solution.

The study required an enormous amount of coordination and work, involving the assistance of patients and families, as well as physicians, nurses, clinical teams, pharmacy staff and others.

It was a difficult sell.

“We needed to recruit patients for the study and then educate them about study guidelines,” Wolf says. “We asked hundreds of staff members to do something for us in addition to their day-to-day duties. On top of this, we asked patients to participate in a therapy where they didn’t know what they would receive.”

Josh Wolf, MD, and Kim Allison

Making science fun

Josh Wolf, MD, and Kim Allison of St. Jude Infectious Diseases are surrounded by some of the items used to promote the ETHEL study.

Friendly reminder

Providing something small, consistent and recognizable could tie all the departments and patients together — alerting everyone and reminding them about the study. The answer was ETHEL, short for ethanol-lock therapy.

“ETHEL became the image for communicating through this study,” Wolf says. “ETHEL’s image greeted every message we sent to those involved.”

Wolf used whatever he could to keep ETHEL front and center for patients and staff — pizza and donuts for nursing staff, milestone messages marking increased enrollment, bracelets that identified patients as part of the study.

It worked. Participation was high, with both staff and patients engaged in the process.

“My feeling was that this portion of my time could really change the future,” Duckworth says. “Processes were being questioned and things were getting figured out. I’m glad I participated, because it helps patients now.”

Surprising outcome

The ETHEL study had results that were definitive, but unexpected.

About half of the patients in both groups developed new or recurring infections, and nearly six of every 10 patients in the ethanol group needed blood thinners to open blocked central lines. Only a third of the standard treatment group required similar thinners.

In short, the study found that ethanol-lock therapy doesn’t work to treat and prevent infections, but that it does increase the risk of line blockages.

“That’s important to know,” Wolf says. “We need to make sure we never use treatments that cause more harm than good.”

Today, Duckworth is a college student who has aspirations of helping the hearing impaired. She also derives satisfaction from knowing future patients can benefit from her experience at St. Jude.

“While you’re there, you help out where you can,” Duckworth says. “Participating in the study was five minutes of my time, and it helped others down the line.”

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