NCT04378998

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)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

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 25, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

May 7, 2020

Status Verified

April 1, 2020

Enrollment Period

4.8 years

First QC Date

April 28, 2020

Last Update Submit

May 6, 2020

Conditions

Terminal Illness

Keywords

AcupunctureNauseaVomitingPalliative care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Interventions

AcupunctureOTHER

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.

Acupuncture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NauseaVomiting

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

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

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 7, 2020

Study Start

January 25, 2015

Primary Completion

October 25, 2019

Study Completion

October 25, 2019

Last Updated

May 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share