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

NCT00550251 | Unknown

• 1 other identifier: SRC2
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Keywords

Nausea; Vomiting; Emesis; Palliative; Terminal; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of PRN Doses of anti-emetics needed

  3 days

Secondary Outcomes (1)

• 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.

  3 days

Study Arms (2)

Acupressure Bands

ACTIVE COMPARATOR

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

Device: Acupressure Wrist Bands (Sea-Bands)

Placebo

PLACEBO COMPARATOR

Elasticated wrist bands without active bead.

Device: Placebo wristbands

Interventions

Acupressure Wrist Bands (Sea-Bands) DEVICE

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

Also known as: Sea-Bands

Acupressure Bands

Placebo wristbands DEVICE

Elasticated wrist bands without active bead.

Also known as: Seaband Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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, 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.

Sponsors & Collaborators

• Sue Ryder Care: lead

Study Sites (1)

Sue Ryder Care Leckhampton Court Hospice

Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Perkins, MB Bch MRCP

  Sue Ryder Care Leckhampton Court Hospice

  STUDY DIRECTOR

Central Study Contacts

Paul Perkins, MB BCh MRCP

CONTACT

+44 1242 230199; paul.perkins@suerydercare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Palliative Medicine

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 29, 2007
• Study Start: July 1, 2010
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

GB (1)