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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220688
• Other study ID #: SRC1
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: October 13, 2009
• Start date: September 2005
• Est. completion date: October 2006

Study information

• Verified date: March 2007
• Source: Gloucestershire Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Vomiting

Intervention

Device:
• Acupressure Wristbands

Locations

Country	Name	City	State
United Kingdom	Sue Ryder Care St. John's Hospice	Moggerhanger	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Brown S, North D, Marvel MK, Fons R. Acupressure wrist bands to relieve nausea and vomiting in hospice patients: do they work? Am J Hosp Palliat Care. 1992 Jul-Aug;9(4):26-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Visual Analogue Scale of nausea measured every 6 hours.
Secondary	Duration of perceived nausea over preceding time period.
Secondary	Number of vomits per 24 hours.
Secondary	Volume of vomit per 24 hours.
Secondary	Adverse effects of acupressure.
Secondary	Number of doses of PRN anti-emetics.
Secondary	Measure of whether the patient felt the intervention helped at the end of the trial.