Michael Braukus<br />Headquarters, Washington November 13, 2003<br />(Phone: 202/358-1979)<br /><br /><br />Jerry Berg<br />Marshall Space Flight Center, Huntsville, Ala.<br />(Phone: 256/544-0034)<br /><br /><br />RELEASE: 03-366<br /><br /><br />NASA LIGHT-EMITTING DIODE TECHNOLOGY BRINGS RELIEF IN CLINICAL <br />TRIALS<br /><br /><br /> A nurse holds a strange-looking device, moving it slowly <br />toward a young patient's face. The note-card-sized device is <br />covered with glowing red lights, but as it comes closer, the <br />youngster shows no fear. He's hopeful this painless procedure <br />using an array of lights will help ease or prevent some of the <br />pain and discomfort associated with cancer treatment.<br /><br /><br />The youngster is participating in the second phase of human <br />clinical trials for this healing device. The first round of <br />tests, by Medical College of Wisconsin researchers at <br />Children's Hospital of Wisconsin in Milwaukee, was so <br />encouraging doctors have expanded the trials to several U.S. <br />and foreign hospitals.<br /><br /><br />"We've already seen how using LEDs can improve a bone-marrow <br />transplant patient's quality of life," said Dr. Harry Whelan, <br />professor of neurology, pediatrics and hyperbaric medicine at <br />the Medical College of Wisconsin. "These trials will hopefully <br />help us take the next steps to provide this as a standard of <br />care for this ailment."<br /><br /><br />The light is produced by light emitting diodes, or LEDs. They <br />are used in hundreds of applications, from electronic clock <br />displays to jumbo TV screens.<br /><br /><br />LEDs provide light for plants grown on the Space Station as <br />part of commercial experiments sponsored by industry. <br />Researchers discovered the diodes also had many promising <br />medical applications, prompting NASA to fund this research as <br />well, through its Marshall Space Flight Center in Huntsville, <br />Ala.<br /><br /><br />Biologists have found that cells exposed to near-infrared <br />light from LEDs, which is energy just outside the visible <br />range, grow 150 to 200 percent faster than cells not <br />stimulated by such light. The light arrays increase energy <br />inside cells that speed up the healing process. <br /><br /><br />In the first stage of the study, use of the LEDs resulted in <br />significant relief to pediatric bone-marrow transplant <br />patients suffering the ravages of oral mucositis, a common <br />side effect of chemotherapy and radiation treatments, <br />according to Dr. David Margolis, an associate professor of <br />pediatrics at the Medical College, working with Dr. Whelan on <br />the study at Children's Hospital.<br /><br /><br />Many times young bone-marrow transplant recipients contract <br />this condition, which produces ulcerations in the mouth and <br />throat, severe pain and in some cases, inflammation of the <br />entire gastro-intestinal tract. Chewing and swallowing become <br />difficult, if not impossible, and a child's overall health is <br />affected because of reduced drinking and eating.<br /><br /><br />"Our first study was very encouraging, and using the LED <br />device greatly reduced or prevented the mucositis problem, <br />which is so painful and devastating to these children," said <br />Whelan. "But we still need to learn more. We're conducting <br />further clinical trials with larger groups and expanded <br />control groups, as required by the U.S. Food and Drug <br />Administration, before the device can be approved and <br />available for widespread use."<br /><br /><br />The treatment device was a 3-by-5-inch portable, flat array of <br />light-emitting diodes. It was held on the outside of a <br />patient's left cheek for just over a minute each day. The <br />process was repeated over the patient's right cheek, but with <br />foil placed between the LED array and the patient, to provide <br />a sham treatment for comparison. There was no treatment of the <br />throat area, which provided the control for the first study. <br /><br /><br />The researchers compared the percentage of patients with <br />ulcerative oral mucositis to historical epidemiological <br />controls. Just 53 percent of the treated patients in the bone-<br />marrow transplant group developed mucositis, considerably less <br />than the usual rate of 70-90 percent. Patients also reported <br />pain reduction in their mouths when compared to untreated pain <br />seven days following bone marrow transplant.<br /><br /><br />The clinical trials are expected to take approximately three <br />years with a total of 80 patients. Participants currently <br />include the Medical College of Wisconsin in Milwaukee; Roswell <br />Park Cancer Institute in Buffalo, N.Y.; and Instituto de <br />Oncologia Pediatrica, in Sao Paulo, Brazil. Other domestic and <br />international hospitals have asked to join the multi-center <br />study.<br /><br /><br />Quantum Devices of Barneveld, Wis., makes the wound-healing <br />LED device. The company specializes in the manufacture of <br />silicon photodiodes, or semiconductor devices used for light <br />detection, and light emitting diodes, for commercial, <br />industrial and medical applications. <br /><br /><br />Supporting materials, including photographs, for this release <br />are available on the Internet at:<br /><br /><br />www.msfc.nasa.gov/news