Acupuncture and electroacupuncture at the P6 point in the wrist and the St 36 point in the anterior tibialis muscle have been been reported to be effective in reducing nausea and emesis occurring acutely (less than 24 hours) after chemotherapy. Although acute chemotherapy-induced nausea and emesis can be also be effectively treated with contemporary pharmacologic anti-emetic regimens, delayed nausea (more than 24 hours to 5 days) after chemotherapy continues to be a clinical management challenge. Patients diagnosed with pediatric solid tumors can be successfully treated using a comprehensive approach that includes highly emetogenic multi-agent chemotherapy. Delayed nausea is often managed by recurrent administration of high dose corticosteroids, with suboptimal therapeutic benefit and frequent undesirable side effects, such as weight gain, growth retardation and increased risk for infections. Recurrent or delayed nausea, in addition to its negative effect on Quality of Life (QOL), may constitute a state of stress for the affected patient, contributing to adverse endocrine, metabolic and immunologic sequelae. Mechanisms of activity of acupuncture in the treatment of acute nausea and emesis have not been clarified. We have initiated a study to determine whether electroacupuncture is effective in the treatment of chemotherapy-induced delayed nausea and emesis in patients with pediatric solid tumors, resulting in improved management of these symptoms and enhanced QOL. We also aim to identify whether acupuncture reduces the stressor state of these chemotherapy-treated patients, reversing its negative effects on the neuro-endocrine and immune systems. Using a randomized, blinded design with control, sham needling, we shall study a total of 52 chemotherapy-naive patients with pediatric solid tumors, age 5-35 years, who will be enrolled for one electroacupuncture treatment period of 7 days during the first chemotherapy cycle, followed by one observation cycle of chemotherapy without acupuncture. 16 study subjects have been enrolled to date: Ewings sarcoma (6), osteosarcoma (2), synovial sarcoma, germ cell tumor, neuroblastoma and other sarcoma (one each respectively). Nine of the 12 completed the study; 2 subjects left the study during cycle 1 (change in diagnosis 1, voluntary withdrawal 1), one subject voluntarily withdrew from the study after cycle 1.? Four study participants were enrolled on-study since the last annual report; however, none of them completed the study period. One patient, a 12 yo female with Hodgkin lymphoma, was enrolled at Columbia Presbyterian but chose to withdraw from the study on day 2 after experiencing grade 1 pain at the acupuncture insertion site in the right wrist. This resolved within 24 hours after cessation of acupuncture. One patient, a 35 yo male with MPNST/NF1, was enrolled at the NIH but the acupuncturist was unable to administer acupuncture due to flaccidity in the patients upper extremities. Two additional patients were enrolled at Childrens Seattle but were withdrawn from the study by investigators prior to treatment; one was determined to be ineligible due to PT/PTT > upper limit of normal and one was unable to be treated due to unavailability of acupuncturists.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Intramural Research (Z01)
Project #
1Z01AT000004-07
Application #
7732849
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
7
Fiscal Year
2008
Total Cost
$192,000
Indirect Cost
Name
National Center for Complementary & Alternative Medicine
Department
Type
DUNS #
City
State
Country
United States
Zip Code
Jindal, Vanita; Ge, Adeline; Mansky, Patrick J (2008) Safety and efficacy of acupuncture in children: a review of the evidence. J Pediatr Hematol Oncol 30:431-42