A nurse holds a strange-looking device, moving it slowly toward a young patient’s face. The note-card-sized device is covered with glowing red lights, but as it comes closer, the youngster shows no fear. He’s hopeful this painless procedure using an array of lights will help ease or prevent some of the pain and discomfort associated with cancer treatment.
The youngster is participating in the second phase of human clinical trials for this healing device. The first round of tests, by Medical College of Wisconsin researchers at Children’s Hospital of Wisconsin in Milwaukee, was so encouraging doctors have expanded the trials to several U.S. and foreign hospitals.
“We’ve already seen how using LEDs can improve a bone-marrow transplant patient’s quality of life,” said Dr. Harry Whelan, professor of neurology, pediatrics and hyperbaric medicine at the Medical College of Wisconsin. “These trials will hopefully help us take the next steps to provide this as a standard of care for this ailment.”
The light is produced by light emitting diodes, or LEDs. They are used in hundreds of applications, from electronic clock displays to jumbo TV screens.
LEDs provide light for plants grown on the Space Station as part of commercial experiments sponsored by industry. Researchers discovered the diodes also had many promising medical applications, prompting NASA to fund this research as well, through its Marshall Space Flight Center in Huntsville, Ala.
Biologists have found that cells exposed to near-infrared light from LEDs, which is energy just outside the visible range, grow 150 to 200 percent faster than cells not stimulated by such light. The light arrays increase energy inside cells that speed up the healing process.
In the first stage of the study, use of the LEDs resulted in significant relief to pediatric bone-marrow transplant patients suffering the ravages of oral mucositis, a common side effect of chemotherapy and radiation treatments, according to Dr. David Margolis, an associate professor of pediatrics at the Medical College, working with Dr. Whelan on the study at Children’s Hospital.
Many times young bone-marrow transplant recipients contract this condition, which produces ulcerations in the mouth and throat, severe pain and in some cases, inflammation of the entire gastro-intestinal tract. Chewing and swallowing become difficult, if not impossible, and a child’s overall health is affected because of reduced drinking and eating.
“Our first study was very encouraging, and using the LED device greatly reduced or prevented the mucositis problem, which is so painful and devastating to these children,” said Whelan. “But we still need to learn more. We’re conducting further clinical trials with larger groups and expanded control groups, as required by the U.S. Food and Drug Administration, before the device can be approved and available for widespread use.”
The treatment device was a 3-by-5-inch portable, flat array of light-emitting diodes. It was held on the outside of a patient’s left cheek for just over a minute each day. The process was repeated over the patient’s right cheek, but with foil placed between the LED array and the patient, to provide a sham treatment for comparison. There was no treatment of the throat area, which provided the control for the first study.
The researchers compared the percentage of patients with ulcerative oral mucositis to historical epidemiological controls. Just 53 percent of the treated patients in the bone-marrow transplant group developed mucositis, considerably less than the usual rate of 70-90 percent. Patients also reported pain reduction in their mouths when compared to untreated pain seven days following bone marrow transplant.
The clinical trials are expected to take approximately three years with a total of 80 patients. Participants currently include the Medical College of Wisconsin in Milwaukee; Roswell Park Cancer Institute in Buffalo, N.Y.; and Instituto de Oncologia Pediatrica, in Sao Paulo, Brazil. Other domestic and international hospitals have asked to join the multi-center study.
Quantum Devices of Barneveld, Wis., makes the wound-healing LED device. The company specializes in the manufacture of silicon photodiodes, or semiconductor devices used for light detection, and light emitting diodes, for commercial, industrial and medical applications.