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

March 27, 2023 updated by: M.D. Anderson Cancer Center

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).

  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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • ES
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint
Electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).
Other Names:
  • 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 an active (responsive) acupuncture site on the bottom of the foot.
Other Names:
  • ES
Procedure: Electro-Stimulation of Yongquan (K1) Acupoint
Electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).
Other Names:
  • ES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Patient Nausea + Vomiting
Time Frame: 2 Years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2007

Primary Completion (Actual)

August 10, 2022

Study Completion (Actual)

August 10, 2022

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0735
  • U19 CA12150301 (Other Grant/Funding Number: NCI)
  • NCI-2012-02114 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cancer

Clinical Trials on Electro-Stimulation of Yongquan (K1) Acupoint

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe