Protocol Number: 02-AT-0172

Title:

A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-Induced Nausea and Vomiting in Patients with Pediatric Sarcomas

Number:

02-AT-0172

Summary:

This study will examine the effectiveness of electroacupuncture in treating delayed nausea and vomiting after receiving chemotherapy for pediatric sarcoma (bone or soft tissue cancer). Studies have shown that acupuncture can help lessen nausea and vomiting on the days of chemotherapy, but delayed nausea and vomiting, occurring 1 to 5 days after chemotherapy, is sometimes more difficult to treat. Electroacupuncture, in which a small electric current is passed through the acupuncture needles, may provide a stronger effect than regular acupuncture, and lessen delayed nausea and vomiting.

Patients between 16 and 35 years of age with a newly diagnosed pediatric sarcoma who have not been treated with chemotherapy and have not previously had acupuncture may be eligible for this study.

All participants will receive standard approved medications for fighting nausea and vomiting. In addition, they will be randomly assigned to one of two electroacupuncture treatment groups: group 1 will have an electroacupuncture regimen that is expected to help control nausea and vomiting; group 2 will be treated with a regimen not expected to affect nausea and vomiting. However, study participants will not be able to tell which of the two regimens they will be receiving. Electroacupuncture will be started within 2 hours before the first chemotherapy treatment and will be given twice a day for the first 2 days and then once a day for a total of 7 days. The procedure will be repeated with the next cycle of chemotherapy, usually 3 to 4 weeks after the first. The study period will include two treatment cycles or a total of 18 electroacupuncture treatments, spanning a total of 6-8 weeks or 2 chemotherapy cycles. This will be followed by a follow up period of another 2 chemotherapy cycles or 6-8 weeks.

A trained acupuncture specialist performs the electroacupuncture. Five small, thin, sterile needles are pushed through the skin in specific areas on both arms and legs. The needle insertion may cause a feeling of pressure, but rarely pain. The needles are left in place for 25 minutes for each treatment, with a low-frequency electrical current flowing through them. Although patients may talk during the treatment, they must lie quietly and try not to move, so as not to affect the treatment or possibly remove or break the fragile needles.

During the acupuncture treatment periods, patients will: 1) mark a calendar 4 times a day indicating whether they feel sick to the stomach and how sick they feel, as well as what medications they took to help with sickness or vomiting; and 2) answer questions once a week about how they feel overall, what activities they can and cannot do, and how much pain they have.

Patients will have blood samples drawn the first day of acupuncture treatment, on another five days during the course of the study, and at the end of the study to examine changes in levels of blood chemistries, insulin, glucose and cell counts. The blood draws will be performed on the days patients would have blood drawn anyway for the follow-up of their chemotherapy effects. They will also provide a 24-hour urine collection for hormone testing to evaluate whether nausea in patients with sarcoma is accompanied by signs of stress, as detected by changes in hormone levels, and whether acupuncture may be able to reduce these effects in addition to reducing delayed nausea.

Sponsoring Institute:

National Center for Complementary and Alternative Medicine (NCCAM)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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 form.

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.

Clinically 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.

Special Instructions: Currently Not Provided

Keywords:

Quality of Life

Stress

Sham Acupuncture

Acupuncture Points

Cancer Pain

Chemotherapy

Nausea and Vomiting

Recruitment Keywords:

Acupuncture

Cancer

Pediatric Sarcoma

Conditions:

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Latreille J, Pater J, etc Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy National Cancer Instituteof Canada Clinical Trials Group J Clin Oncol 1998 Mar;16(3):1174-8 PMID: 95082

Morrow GR, Hickok JT, Burish TG, Rosenthal SN Frequency and clinical implications of delayed nausea and delayed emesisAm J Clin Oncol 1996 Apr;19(2):199-203PMID: 8610650

Stewart DA, Gyonyor E High-dose melphalan +/- total body irradiation and autologous hematopoietic stemcell rescue for adult patients with Ewing's sarcoma or peripheralneuroectodermal tumorBone Marrow Transplant 1996 Aug;18(2):315-8PMID: 8864440

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