Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?

This study has been completed.
Sponsor:
Information provided by:
Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220688
First received: September 16, 2005
Last updated: October 13, 2009
Last verified: March 2007
  Purpose

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


Condition Intervention
Cancer
Device: Acupressure Wristbands

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?

Resource links provided by NLM:


Further study details as provided by Gloucestershire Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 1.Visual Analogue Scale of nausea measured every 6 hours.

Secondary Outcome Measures:
  • 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.
  • Measure of whether the patient felt the intervention helped at the end of the trial.

Estimated Enrollment: 10
Study Start Date: September 2005
Estimated Study Completion Date: October 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220688

Locations
United Kingdom
Sue Ryder Care St. John's Hospice
Moggerhanger, Bedfordshire, United Kingdom, MK44 3RJ
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Paul Perkins, MB BCh MRCP Sue Ryder Care St. John's Hospice
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00220688     History of Changes
Other Study ID Numbers: SRC1
Study First Received: September 16, 2005
Last Updated: October 13, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Gloucestershire Hospitals NHS Foundation Trust:
nausea
vomiting
palliative
acupressure

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014