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

Terminal Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378998
• Other study ID #: 1-10-72-291-14
• Status: Completed
• Phase: N/A
• Start date: January 25, 2015
• Est. completion date: October 25, 2019

Study information

• Verified date: April 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Terminal Illness
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 nausea score from before intervention to three day after the intervention
Primary	Change in vomiting	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