Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin

Study Overview
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Brief Summary
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Objectives: 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, investigator's 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). 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. 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.

Detailed Description
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Nausea and vomiting are common side effects caused by chemotherapy. Some studies have shown that acupuncture can be helpful in treating nausea and vomiting. Acupuncture uses very thin needles inserted at certain points on the body that are believed to affect bodily functions. Researchers want to study the effects on nausea and vomiting of giving electro-stimulation (using wires attached to the body to provide very small electrical shocks to the skin) to an acupuncture site, compared to giving electro-stimulation to a inactive site (a site that does not respond to acupuncture). If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to be in 1 of 2 groups. Participants in one group will receive electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot. Participants in the other group will receive electro-stimulation at a inactive site on the bottom of the foot (a placebo site). Participants in both groups will have electro-stimulation on the feet. You will sit or lie down in bed. The acupuncturist will wet the points with a cotton ball dipped in water and attach the electrodes of the electro-stimulating instrument to the bottom of your feet. The electrodes are little paddles that will be attached with tape. The acupuncturist will begin slowly increasing the stimulation to a level you can withstand comfortably. This will last about 30 minutes. The stimulation will occur about 1-2 hours before your TAI chemotherapy on the first day, and then between 7-9 A.M. on the next 5 days. After each electro-stimulation procedure, your vital signs will be measured, you will complete quality-of-life questionnaires, and you will be asked about hiccups and diet tolerance (how nausea has affected your ability to eat or how much you eat). After your last electro-stimulation, you will also have a TCM diagnosis. This will include diagnosis by a doctor as well as by using a heart-rate machine and taking a photograph of your tongue. Blood (about 1 teaspoon) will also be drawn to check your liver function about 6 days after the treatments. You will be given the standard medicines if you experience uncontrolled nausea or vomiting while on this study. Your total participation on this study will last less than 2 weeks. This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at the Fudan University Cancer Hospital.

Official Title
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Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin

Conditions
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Liver Cancer, Liver Metastasis

Intervention / Treatment
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* Procedure: Electro-Stimulation of Yongquan (K1) Acupoint
* Procedure: Electro-Stimulation of Yongquan (K1) Acupoint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who will undergo TAI (transarterial infusion) for liver primary or other primary with liver metastasis Between 18-75 years old Patients who will receive TAI using cisplatin or oxaliplatin Must give informed consent If patients is female and of child bearing potential, must have a negative urine pregnancy test Exclusion Criteria: Has local skin infections at or near the acupoints Previous TAI treatment using platinum-based chemotherapy History of cerebrovascular or cardiovascular accident or spinal cord injury Nausea and vomiting induced by intestinal obstruction Has cardiac pacemaker 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 Currently using acupuncture Vomiting or using 5-HT3 receptor antagonists or other antiemetic in 24 hours before TAI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-Stimulation (Active Site)<br>Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot. | Procedure: Electro-Stimulation of Yongquan (K1) Acupoint<br>* Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.<br>* Other names: ES;|
| Experimental: Electro-Stimulation (Inactive Site)<br>Electro-stimulation at a inactive site on the bottom of the foot (a placebo site). | Procedure: Electro-Stimulation of Yongquan (K1) Acupoint<br>* Electro-stimulation at a inactive site on the bottom of the foot (a placebo site).<br>* Other names: ES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Patient Nausea + Vomiting | Vomiting and nausea will be classified according to the WHO criteria. The four levels of nausea are defined as: 0=no nausea, 1=slight nausea, 2=obvious nausea affecting normal life, and 3-4=continual and serious nausea. The four levels of vomiting are defined as: 0=no vomiting, 1=vomiting 1-2 times/day, 2=vomiting 2-4 times/day, and 3-4=vomiting 5 times/day. | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Vomiting, Electro-Stimulation, ES, K1 Acupuncture Point, Yongquan Acupuncture Point, TAI, transarterial infusion, liver metastasis, chemotherapy induced nausea and vomiting, CINV, Cisplatin, Oxaliplatin