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

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)

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Key information

Conditions

Terminal Illness Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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 outcomes

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 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: May 7, 2020
Registry last updated: May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed