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Study Summary
No. 2006-0735:.......Liver......Joseph S. Chiang......Anesthesiology
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Study Summary Title
Study Summary
Number:		2006-0735
Study Title:Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin
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Physician New Patient Referral
Name:Joseph S. ChiangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:AnesthesiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5363
Contact us about clinical trials
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General Information
Disease Group:LiverSupported By:N/A
Phase of Study:N/AReturn
Visit:		none
Treatment
Agents:		AcupunctureHome Care:none
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		The duration of their chemotherapy regimen.
Description/
Intervention:		The goal of this clinical research study is to learn the effect of acupoint
electro-stimulation on preventing nausea and vomiting caused by receiving
cisplatin or oxaliplatin treatment for liver cancer. Researchers also want to
see if this stimulation will affect aspects of your quality-of-life.
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Study Objectives / Outcomes
This protocol is part of a larger grant funded by the NCI to create an international research center to study Traditional Chinese Medicine (TCM). All of the patients enrolled in this study will be treated at the Cancer Hospital, Fudan University, our sister institution in Shanghai, China. No patients will be seen at MDACC. This protocol will be overseen by the Fudan University Institutional Review Board (IRB00002408) which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002). The research nurses have received training at MDACC and will receive regular oversight by MDACC personnel.

The purpose of this randomized, placebo controlled study is to determine the effects of K1 acustimulation at controlling chemotherapy induced nausea and vomiting (CINV).

1. The primary aim of this study is to determine the effects of electro-stimulation of Yongquan (K1) acupoint on preventing nausea and vomiting induced by cisplatin or oxaliplatin.

2. The secondary aim is to observe the effects of electro-stimulation (ES) of Yongquan (K1) acupoint on pain, insomnia, abdominal distention, dizziness, and general sense of well-being.
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Study Status Information
Study Activation / Registration Date:01/04/2007
IRB Review and Approval Date:11/01/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:100
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) All patients who will undergo TAI (transarterial infustion) for liver primary or other primary with liver metastasis

2) Between 18-75 years old

3) Patients who will receive TAI using cisplatin or oxaliplatin

4) Must give informed consent

5) If patients is female and of child bearing potential, must have a negative urine pregnancy test
Exclusion Criteria:1) Has local skin infections at or near the acupoints

2) Previous TAI treatment using platinum-based chemotherapy

3) History of cerebrovascular or cardiovascular accident or spinal cord injury

4) Nausea and vomiting induced by intestinal obstruction

5) Has cardiac pacemaker

6) Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process

7) Currently using acupuncture

8) Vomiting or using 5-HT3 receptor antagonists or other antiemetic in 24 hours before TAI.
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Links
Registration Number: NCT00430313
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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