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, Maryland.
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 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 nccam.nih.gov.
|
