Back to results

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

Primary Purpose

Terminal Illness

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Terminal Illness focused on measuring Acupuncture, Nausea, Vomiting, Palliative care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Usual care

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in nausea score

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 vomiting

Unit of measure: Incidence of vomiting using the outcome measure question: Yes or No

Secondary Outcome Measures

Full Information

NCT ID

NCT04378998

First Posted

April 28, 2020

Last Updated

May 6, 2020

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT04378998

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 25, 2015 (Actual)

Primary Completion Date

October 25, 2019 (Actual)

Study Completion Date

October 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Terminal Illness

Keywords

Acupuncture, Nausea, Vomiting, Palliative care

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

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.

Arm Title

Usual care

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in nausea score

Description

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

Time Frame

Change in nausea score from before intervention to three day after the intervention

Title

Change in vomiting

Description

Unit of measure: Incidence of vomiting using the outcome measure question: Yes or No

Time Frame

Change in vomiting from before intervention to four day after the intervention

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs