NCT00220688

Brief Summary

Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

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

September 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

October 14, 2009

Status Verified

March 1, 2007

First QC Date

September 16, 2005

Last Update Submit

October 13, 2009

Conditions

Keywords

nauseavomitingpalliativeacupressure

Outcome Measures

Primary Outcomes (1)

  • 1.Visual Analogue Scale of nausea measured every 6 hours.

Secondary Outcomes (6)

  • Duration of perceived nausea over preceding time period.

  • Number of vomits per 24 hours.

  • Volume of vomit per 24 hours.

  • Adverse effects of acupressure.

  • Number of doses of PRN anti-emetics.

  • +1 more secondary outcomes

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of advanced cancer with an estimated prognosis of less than 1 year but more than 3 days.
  • Describe their nausea as at least moderate on a Likert scale OR at have had at least one vomit per day for the last three days.
  • Have an underlying cause for their nausea which is thought to be irreversible OR the patient has made an autonomous choice not to proceed with treatment for any potentially reversible cause (for example surgery for obstruction or drainage of ascites).
  • Can be male or female patients but must be over the age of 18.
  • Have signed a consent form prior to entering the study.
  • If patients are taking corticosteroids the dosage should be stable for 3 days before and during the trial.
  • Be thought to be well enough to complete the 3 day trial.

You may not qualify if:

  • Arm lymphoedema.
  • Weakness, fatigue or confusion sufficient that patient is unable to take part.
  • Previous history of acupuncture/acupressure for nausea or vomiting.
  • History of Parkinsonism or Parkinsonism on examination.
  • Patients will not be enrolled if they are sharing a room with another patient taking part in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sue Ryder Care St. John's Hospice

Moggerhanger, Bedfordshire, MK44 3RJ, United Kingdom

Location

Related Publications (1)

  • Brown S, North D, Marvel MK, Fons R. Acupressure wrist bands to relieve nausea and vomiting in hospice patients: do they work? Am J Hosp Palliat Care. 1992 Jul-Aug;9(4):26-9. doi: 10.1177/104990919200900409.

MeSH Terms

Conditions

NeoplasmsNauseaVomiting

Condition Hierarchy (Ancestors)

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

Study Officials

  • Paul Perkins, MB BCh MRCP

    Sue Ryder Care St. John's Hospice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Study Completion

October 1, 2006

Last Updated

October 14, 2009

Record last verified: 2007-03

Locations