This study will investigate the efficacy of electroacupuncture to reduce delayed chemotherapy-induced nausea in pediatric and young adult patients with pediatric sarcoma.

Condition	Treatment or Intervention	Phase
Sarcoma Nausea Vomiting	Procedure: Electroacupuncture	Phase II

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.

Ages Eligible for Study:  16 Years   -   35 Years,  Genders Eligible for Study:  Both

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

Patrick J. Mansky, MD      301-435-4845    manskyp@mail.nih.gov

Maryland
      Laboratory of Clinical Investigation, National Center for Complementary and Alternative Medicine, Bethesda,  Maryland,  20892,  United States; Recruiting

Study chairs or principal investigators

Patrick J. Mansky, MD,  Principal Investigator,  National Center for Complementary and Alternative Medicine, National Institutes of Health   

Study ID Numbers:  02-AT-0172
Record last reviewed:  October 2003
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00034996
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08