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A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas Clinical research trials and A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas. A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas clinical trial. Participants frequently obtain the most expert healthcare available for their A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas  A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas
A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas
For Condition: Nausea,Vomiting,Sarcoma
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) , National Cancer Institute (NCI),National Institute of Dental and Craniofacial Research (NIDCR)
Synopsis: This study will investigate the efficacy of electroacupuncture to reduce delayed chemotherapy-induced nausea in pediatric and young adult patients with pediatric sarcoma.
Details: Acupuncture has been found to be effective in reducing chemotherapy-induced acute emesis according to a number of studies and a recent report by the NIH consensus conference on acupuncture held in 1997. Acupuncture and electroacupuncture at the P6 point in the wrist area and the St 36 point in the m. tibialis anterior have been widely used for treatment in chemotherapy-induced acute nausea and emesis research studies. While acute chemotherapy-induced emesis and nausea can be effectively treated with contemporary anti-emetic regimens, delayed nausea, defined as nausea occurring between 24 hours and up to 5 days after completion of chemotherapy , continue to be a management challenge. Patients diagnosed with pediatric sarcomas can be successfully treated using a comprehensive treatment approach including highly emetogenic multi-agent chemotherapy. Delayed nausea frequently is managed by recurrent administration of high dose corticosteroids, resulting in undesirable side effects including 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 that may contribute to recognized endocrine, metabolic and immunologic sequelae of chronic stress that are emerging from research in cancer survivors. Mechanisms of activity of acupuncture in the treatment of emesis and nausea have not been clearly identified. This study hypothesizes that electroacupuncture may be effective in the treatment of chemotherapy-induced delayed nausea in patients with pediatric sarcomas, resulting in improved management of delayed nausea and emesis and improvement of QOL. It also aims at identifying potential underlying mechanisms of action such as reduction of a state of stress with its negative effects on the neuro-endocrine-immune system and QOL. In a randomized, blinded design with control sham needling, a total of 52 chemotherapy-naïve patients with pediatric sarcomas age 16-35 years will be enrolled for two electroacupuncture treatment periods of 7 days each during the first two chemotherapy cycles.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/35 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Newly diagnosed pediatric sarcoma - No previous exposure to systemic chemotherapy - Eligible for POB sarcoma protocols 97-C-0050, 97-C-0052, 00-C-0092 (non-osteosarcoma) or 99-C-0125 (osteosarcoma), or to be treated on the Natural History Protocol 98-C-0037 with vincristine, adriamycin, cyclophosphamide, etoposide, ifosphamide (non-osteosarcoma) or an adriamycin/cisplatin based regimen (osteosarcoma). - Age at time of study entry 16-35 years - Willing to participate in experimental protocol including randomization - All minors must be able and willing to give assent - All adult study participants must be willing and able to sign a consent from - Normal PT, PTT - Platelet count greater than 50,000 independent of transfusions. Exclusion Criteria - Glucocorticoid therapy within the last 4 weeks prior to study entry or currently required - Clinical or radiographic signs of spinal cord compression - Prior experience with acupuncture - Casting of one or more extremities or any other condition that may prevent access to designated acupuncture points. - Known clotting disorders including hemophilia - Current use of anticoagulant medications - Cognitive impairment
Total Enrollment: 52
Location and Contact Information:
Overall Study Official:
PatrickMansky, Principal Investigator, National Center for Complementary and Alternative Medicine, National Institutes of Health
Laboratory of Clinical Investigation, National Center for Complementary and Alternative Medicine *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting
Additional Information:
Study ID Numbers: 02-AT-0172;
Study Start Date: May 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034996
Other Nausea Studies:
1. A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas
2. Ginger Control of Chemotherapy Induced Nausea and Vomiting
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A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas
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