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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00430313
First received: January 30, 2007
Last updated: September 11, 2014
Last verified: September 2014
  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).

  • 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.

Condition Intervention
Liver Cancer
Liver Metastasis
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Acupoint Electro-stimulation on Preventing Nausea and Vomiting Induced by Cisplatin or Oxaliplatin

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Level of Patient Nausea + Vomiting [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electro-Stimulation (Active Site)
Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint
Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.
Other Name: ES
Experimental: Electro-Stimulation (Inactive Site)
Electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint
Electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).
Other Name: ES

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. All patients who will undergo TAI (transarterial infusion) 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 patient 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430313

Locations
China
Fudan University Cancer Hospital
Shanghai, China
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Joseph S. Chiang, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00430313     History of Changes
Other Study ID Numbers: 2006-0735, U19 CA12150301
Study First Received: January 30, 2007
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Nausea
Vomiting
Electro-Stimulation
ES
K1 Acupuncture Point
Yongquan Acupuncture Point
TAI
transarterial infusion
liver metastasis
chemotherapy induced nausea and vomiting
CINV
Cisplatin
Oxaliplatin

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Vomiting
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Oxaliplatin
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014