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

This study is currently recruiting participants.
Verified March 2012 by Sue Ryder Care
Sponsor:
Information provided by (Responsible Party):
Paul Perkins, Sue Ryder Care
ClinicalTrials.gov Identifier:
NCT00550251
First received: October 25, 2007
Last updated: March 17, 2012
Last verified: March 2012
History of Changes
  Purpose

Pilot study completed - power calculation performed. Now formal double blind randomized study comparing active with placebo wristbands for nausea in palliative care patients to be carried out.


Condition Intervention
Nausea
Vomiting
 Device: Acupressure Wrist Bands (Sea-Bands)
Device: Placebo wristbands

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sue Ryder Care:

Primary Outcome Measures:
  • Number of PRN Doses of anti-emetics needed [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analogue Scale of nausea; duration of perceived nausea; number of vomits per 24 hours; volume of vomit per 24 hours; adverse effects of acupressure; measure of whether the patient felt the intervention helped. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 58
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acupressure Bands
Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
 Device: Acupressure Wrist Bands (Sea-Bands)
Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
Other Name: Sea-Bands
Placebo Comparator: Placebo
Elasticated wrist bands without active bead.
 Device: Placebo wristbands
Elasticated wrist bands without active bead.
Other Name: Seaband Placebo

Detailed Description:

Terminally ill hospice in-patients suffering with nausea will be randomized to active or placebo acupressure bands. The study will last 3 days and they will be allowed to continue regular or have PRN anti-emetics during the study.

Assessors and patients will both be blinded to whether they patients are receiving active or placebo bands.

  Eligibility

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

Inclusion Criteria:

  1. Have a diagnosis of advanced cancer with an estimated prognosis of less than 1 year but more than 3 days.
  2. 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.
  3. 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).
  4. Can be male or female patients but must be over the age of 18.
  5. Have signed a consent form prior to entering the study.
  6. If patients are taking corticosteroids the dosage should be stable for 3 days before and during the trial.
  7. Be thought to be well enough to complete the 3 day trial.

Exclusion criteria:

  1. Arm lymphoedema.
  2. Weakness, fatigue or confusion sufficient that patient is unable to take part.
  3. Previous history of acupuncture/acupressure for nausea or vomiting, or history of use of acupressure by a close relative.
  4. History of Parkinsonism or Parkinsonism on examination.
  5. Patients will not be enrolled if they are sharing a room with another patient taking part in the study.
  6. Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550251

Contacts
Contact: Paul Perkins, MB BCh MRCP +44 1242 230199 paul.perkins@suerydercare.org

Locations
United Kingdom
Sue Ryder Care Leckhampton Court Hospice Recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
Contact: Paul Perkins, MB BCh MRCP     +441242230199     paul.perkins@suerydercare.org    
Principal Investigator: Paul Perkins, MB BCh MRCP            
Sponsors and Collaborators
Sue Ryder Care
Investigators
Study Director: Paul Perkins, MB Bch MRCP Sue Ryder Care Leckhampton Court Hospice
  More Information

No publications provided

Responsible Party: Paul Perkins, Consultant in Palliative Medicine, Sue Ryder Care
ClinicalTrials.gov Identifier: NCT00550251     History of Changes
Other Study ID Numbers: SRC2
Study First Received: October 25, 2007
Last Updated: March 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sue Ryder Care:
Nausea
Vomiting
Emesis
 Palliative
Terminal
Cancer

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

ClinicalTrials.gov processed this record on June 17, 2013