NCT00430313

Brief Summary

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. 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. 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
15.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

15.6 years

First QC Date

January 30, 2007

Last Update Submit

March 27, 2023

Conditions

Liver CancerLiver Metastasis

Keywords

NauseaVomitingElectro-StimulationESK1 Acupuncture PointYongquan Acupuncture PointTAItransarterial infusionliver metastasischemotherapy induced nausea and vomitingCINVCisplatinOxaliplatin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Electro-Stimulation (Active Site)

EXPERIMENTAL

Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.

Procedure: Electro-Stimulation of Yongquan (K1) Acupoint

Electro-Stimulation (Inactive Site)

EXPERIMENTAL

Electro-stimulation at a inactive site on the bottom of the foot (a "placebo" site).

Procedure: Electro-Stimulation of Yongquan (K1) Acupoint

Interventions

Electro-Stimulation of Yongquan (K1) AcupointPROCEDURE

Electro-stimulation at an active (responsive) acupuncture site on the bottom of the foot.

Also known as: ES
Electro-Stimulation (Active Site)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Liver NeoplasmsNauseaVomiting

Interventions

Acupuncture Points

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MeridiansAcupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Lorenzo Cohen, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

January 4, 2007

Primary Completion

August 10, 2022

Study Completion

August 10, 2022

Last Updated

March 29, 2023

Record last verified: 2023-03