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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00430313 |
Purpose
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, the investigators' 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).
| Condition | Intervention |
|---|---|
|
Liver Cancer Liver Metastasis |
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Electro-Stimulation (Active Site)
|
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint
Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.
|
|
2: Experimental
Electro-Stimulation (Inactive Site)
|
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint
Electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).
|
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).
Before you can start treatment on this study, you will have screening tests. These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate). You will be asked about drugs you have taken in the last 30 days. You will be asked to complete 2 questionnaires about your health and quality-of-life. These should take about 5 minutes to complete. A traditional Chinese medicine (TCM) diagnosis will be completed by research staff. This will include a check of your pulse, examination of your tongue, and answering some general questions. The assessment will be conducted by a doctor, as well as by using a heart-rate machine and taking a photograph of your tongue.
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 transarterial infusion (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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joseph S. Chiang, MD | 713-794-5363 |
| China | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, China | |
| Principal Investigator: | Joseph S. Chiang, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Joseph S. Chiang, MD/Professor ) |
| Study ID Numbers: | 2006-0735, U19 CA12150301 |
| Study First Received: | January 30, 2007 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00430313 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Nausea Vomiting Electro-Stimulation ES K1 Acupuncture Point Yongquan Acupuncture Point TAI |
transarterial infusion liver metastasis chemotherapy induced nausea and vomiting CINV Cisplatin Oxaliplatin |
|
Liver Diseases Vomiting Digestive System Neoplasms Signs and Symptoms, Digestive Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Liver Neoplasms Signs and Symptoms Neoplasms |
Neoplastic Processes Oxaliplatin Neoplasms by Site Digestive System Diseases Pathologic Processes Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Neoplasm Metastasis |