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

October 13, 2009 updated by: Gloucestershire Hospitals NHS Foundation Trust
Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pilot The study will be piloted with 10 patients to ensure that the protocol is acceptable to patients and to inform a formal power calculation for a larger study. Patients will be randomized to each arm according to a randomization programme at www.randomization.com.

Arm 1 Instruction and placement of acupressure bands at the P6 acupuncture point bilaterally. This point is located 2 cun (a Chinese measurement equal to approximately 3cm) proximal to the midpoint of the transverse crease of the wrist between the tendons of palmaris longus and flexor carpi radialis.

Arm 2 Instruction and placement of sham acupressure bands P6 acupuncture point bilaterally. Sham acupressure bands have no stud to stimulate P6.

Patients may choose to have regular anti-emetics or a subcutaneous syringe driver after 24 hours if they are not happy with their level of nausea and vomiting.

4. STUDY POPULATION

4.1 Source and Number of Patients: Hospice in-patients. 10 patients for pilot.

4.2 Inclusion Criteria

Patients must meet the following criteria to be eligible to participate in the study:

  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.

4.3 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.
  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.

5. OUTCOME MEASURES

  1. Visual Analogue Scale of nausea measured every 6 hours. If patients are asleep they will not be waken for assessments overnight.
  2. Duration of perceived nausea over preceding time period.
  3. Number of vomits per 24 hours.
  4. Volume of vomit per 24 hours.
  5. Adverse effects of acupressure.
  6. Number of doses of PRN anti-emetics.
  7. Measure of whether the patient felt the intervention helped at the end of the trial.

6. QUANTITATIVE ANALYSIS

This pilot will allow a formal power calculation to be performed to elucidate how many patients need to be randomized to the full study.

Statistical analysis will be performed by Sarah Vowler at the Centre for Applied Medical Statistics.

Study Type

Interventional

Enrollment

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bedfordshire
      • Moggerhanger, Bedfordshire, United Kingdom, MK44 3RJ
        • Sue Ryder Care St. John's Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1.Visual Analogue Scale of nausea measured every 6 hours.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gloucestershire Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Paul Perkins, MB BCh MRCP, Sue Ryder Care St. John's Hospice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRC1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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