- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00220688
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?
Study Overview
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:
- 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.
4.3 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.
5. OUTCOME MEASURES
- Visual Analogue Scale of nausea measured every 6 hours. If patients are asleep they will not be waken for assessments overnight.
- 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.
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Bedfordshire
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Moggerhanger, Bedfordshire, United Kingdom, MK44 3RJ
- Sue Ryder Care St. John's Hospice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Paul Perkins, MB BCh MRCP, Sue Ryder Care St. John's Hospice
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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