June 13, 2002 The National Center for Complementary and Alternative Medicine (NCCAM) has launched a clinical trial of electroacupuncture to determine if it reduces the delayed nausea experienced by cancer patients following chemotherapy. This study marks the first clinical trial for NCCAM's Division of Intramural Research, which was established in April 2001, at the National Institutes of Health (NIH) in Bethesda, MD.
Electroacupuncture, which has been in use for decades, is a variation of traditional acupuncture. In this process, acupuncture needles are placed at selected points and then pulsed with an electric current to stimulate the acupuncture points. Electroacupuncture has been studied for a variety of health conditions including treatment of pain and relief of acute nausea following chemotherapy. Acute nausea occurs within the first 24 hours after chemotherapy, whereas delayed nausea occurs 24 hours to 5 days after chemotherapy.
"The scientific evidence supporting use of electroacupuncture for relief of acute nausea following chemotherapy is very encouraging," said Marc Blackman, M.D., Director of NCCAM's Division of Intramural Research. "Now we need to look at its potential utility for treating delayed post-chemotherapy nausea, a problem for many cancer patients that needs to be investigated."
The randomized trial will enroll 52 patients, aged 16 to 35 years, who have been diagnosed with pediatric sarcomas and are starting their first course of chemotherapy. Standard treatment for pediatric sarcomas involves chemotherapy regimens that are likely to cause both acute and delayed nausea. Patients will be divided into two groups--a treatment group that receives electroacupuncture and a control group that receives sham needling. Sham needling involves placement of acupuncture needles near acupuncture points, but in sites that are considered to have no treatment effect on nausea or emesis (vomiting). The patients and investigators, except for the acupuncturist, will both be masked (double-masked) as to type of treatment provided. Both patient groups will receive standard anti-nausea drugs for treatment of acute nausea and vomiting. Trial results will be expected in approximately 4 years.
"At present, we can treat the acute nausea that accompanies chemotherapy with conventional medications, but delayed nausea is tough to manage," said principal investigator Patrick Mansky, M.D., a research oncologist and staff clinician in NCCAM's Division of Intramural Research. "We hope that this trial will help reveal the value of electroacupuncture in managing delayed chemotherapy-induced nausea as well as other possible benefits."
Unlike acute chemotherapy-induced nausea, delayed nausea does not respond well to medications. To manage delayed nausea, cancer patients are often prescribed glucocorticoids, a type of steroids, which can lead to unwanted side effects, such as weight gain, retarding of growth, or susceptibility to infection. It also appears that delayed nausea may contribute to stress in patients and the negative effects that stress can induce. Therefore, finding an effective alternative may help patients avoid the potential side effects of glucocorticoids and stress.
"Our first intramural clinical trial addresses a significant problem for many cancer patients," said Stephen E. Straus, M.D., NCCAM Director. "If electroacupuncture does reduce delayed nausea following chemotherapy, oncologists will have a treatment option that may spare patients from negative side effects associated with certain medications. This study demonstrates NCCAM's commitment to draw upon the vast research resources and expertise of NIH intramural scientists to assess promising CAM approaches to public health problems."
Studies of both acupuncture and electroacupuncture show that the techniques can be effective for treatment of chemotherapy-induced acute nausea and produce few or no side effects. Trial participants will receive electroacupuncture or sham needling for 7 days (twice daily on days 1 and 2 and once daily on days 3 through 7) starting with the first day of chemotherapy. This will be repeated for a second cycle of chemotherapy. The researchers will followup with patients after two additional cycles of chemotherapy.
Three experienced and licensed acupuncturists, Jay Shah, M.D., Adeline Ge, M.D., and Usha Chaudhry, M.D., of the NIH Clinical Center's Department of Rehabilitation Medicine, will coordinate and perform all of the electroacupuncture and sham needling procedures. Two particular acupuncture points, known as P6 (near the wrist) and St36 (near the knee), have been tested in previous trials for nausea relief and will be employed in this trial. Both patient groups will also have an additional needle placed at a sham point common to both groups to serve as an added control. In addition to determining the effectiveness of electroacupuncture as an approach to treating delayed nausea, the researchers also hope to verify that the specific acupuncture points P6 and St36 are effective for treating delayed nausea.
Patient recruitment for the trial began at the NIH Clinical Center in May 2002. To learn more about this trial, please visit NCCAM's clinical trials page at http://nccam.nih.gov/clinicaltrials.
The National Center for Complementary and Alternative Medicine (NCCAM) is dedicated to exploring complementary and alternative medical (CAM) practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. For additional information, call NCCAM's Clearinghouse toll free at 1-888-644-6226, or visit the NCCAM Web site at http://nccam.nih.gov.
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