Is Acupuncture Able to Reduce Nausea and Vomiting in the Terminal Ill Patient

May 6, 2020 updated by: University of Aarhus
A comparative effectiveness research design was used. The sample size was calculated to 136 patients, who were randomized to an intervention group and a control group respectively. The patients were terminal ill patients enrolled to three in-bed hospices in Denmark and nausea and vomiting were measured using EORTC QlQ-c15-PAL (European Organisation for Research and Treatment of Cancer, Quality of Life Questionaire, core 15, Palliation)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The terminal ill patient is suffering from many different symptoms. In total 70% are suffering from nausea and vomiting due to the wide spread of cancer or due to side effects of treatment. Often the antiemetic's are not able to reduce symptoms to a level that enable the patient to experience quality in life in the last days of his life. The investigators had some experience with acupuncture as a complementary therapy but the investigators wanted more systematically to investigate if acupuncture is able to reduce the terminal ill patient´s nausea and vomiting. Literature show that acupuncture is able to reduce nausea and vomiting in patients receiving chemotherapy, but there is no literature that support the ability of acupuncture to reduce nausea and vomiting in the terminal ill patient.

The purpose of this study was to generate evidence based knowledge close to practice regarding the effect of acupuncture in reducing nausea and vomiting in the terminal ill patient.

Participants:

Terminal ill patients suffering from nausea and/or vomiting

Interventions:

The intervention group received usual care plus acupuncture for three days. The acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Yin Tang were used. The control group received usual care.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to participate due to cognitive ability
  • Nausea
  • Admitted to in-bed hospice

Exclusion Criteria:

  • Not able to participate due to cognitive impairment
  • Lymphedema in the area of acupuncture site

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Acupuncture
The intervention group received usual care plus acupuncture for three days. The acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Ying Tang were used.
Other: Acupuncture
The intervention group received usual care plus acupuncture for three days. The acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Yin Tang were used. The control group received usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nausea score
Time Frame: Change in nausea score from before intervention to three day after the intervention
Using EORTC QLQ-c15-PAL, the nausea item. Values: not at all, a little, quite a bit, very much. Very much is the worse outcome
Change in nausea score from before intervention to three day after the intervention
Change in vomiting
Time Frame: Change in vomiting from before intervention to four day after the intervention
Unit of measure: Incidence of vomiting using the outcome measure question: Yes or No
Change in vomiting from before intervention to four day after the intervention

Collaborators and Investigators

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

Sponsor

University of Aarhus

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 25, 2015

Primary Completion (Actual)

October 25, 2019

Study Completion (Actual)

October 25, 2019

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-291-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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