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

Primary Purpose

Nausea, Vomiting

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Acupressure Wrist Bands (Sea-Bands)

Placebo wristbands

About this trial

This is an interventional treatment trial for Nausea focused on measuring Nausea, Vomiting, Emesis, Palliative, Terminal, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, or history of use of acupressure by a close relative.
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.
Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.

Sites / Locations

Sue Ryder Care Leckhampton Court HospiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acupressure Bands

Placebo

Arm Description

Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.

Elasticated wrist bands without active bead.

Outcomes

Primary Outcome Measures

Number of PRN Doses of anti-emetics needed

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.

Full Information

NCT ID

NCT00550251

First Posted

October 25, 2007

Last Updated

May 3, 2018

Sponsor

Sue Ryder Care

1. Study Identification

Unique Protocol Identification Number

NCT00550251

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sue Ryder Care

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea, Vomiting

Keywords

Nausea, Vomiting, Emesis, Palliative, Terminal, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupressure Bands

Arm Type

Active Comparator

Arm Description

Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Elasticated wrist bands without active bead.

Intervention Type

Device

Intervention Name(s)

Acupressure Wrist Bands (Sea-Bands)

Other Intervention Name(s)

Sea-Bands

Intervention Description

Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.

Intervention Type

Device

Intervention Name(s)

Placebo wristbands

Other Intervention Name(s)

Seaband Placebo

Intervention Description

Elasticated wrist bands without active bead.

Primary Outcome Measure Information:

Title

Number of PRN Doses of anti-emetics needed

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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, or history of use of acupressure by a close relative. 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. Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Perkins, MB BCh MRCP

Phone

+44 1242 230199

paul.perkins@suerydercare.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Perkins, MB Bch MRCP

Organizational Affiliation

Sue Ryder Care Leckhampton Court Hospice

Official's Role

Study Director

Facility Information:

Facility Name

Sue Ryder Care Leckhampton Court Hospice

City

Cheltenham

State/Province

Gloucestershire

ZIP/Postal Code

GL53 0QJ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Perkins, MB BCh MRCP

Phone

+441242230199

paul.perkins@suerydercare.org

First Name & Middle Initial & Last Name & Degree

Paul Perkins, MB BCh MRCP

12. IPD Sharing Statement

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

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