CancerNCT00220688
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?
A study testing Acupressure Wristbands in people with Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Acupressure Wristbands
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sue Ryder Care St. John's Hospice
Moggerhanger, Bedfordshire, MK44 3RJ
About this study
Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Cancer
- Being tested
- Acupressure Wristbands
- Keywords
- nausea, vomiting, palliative, acupressure
- Medical subject headings
- Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure WristbandsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Visual Analogue Scale of nausea measured every 6 hours.
Secondary outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Paul Perkins, MB BCh MRCP, Principal investigator, Sue Ryder Care St. John's Hospice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220688
- Sponsor's protocol ID
- SRC1
- Status last verified
- Mar 2007
- First submitted
- 16 Sep 2005
- Last updated
- 14 Oct 2009
- Results posted
- No
Publications
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. doi: 10.1177/104990919200900409.
PubMed 1457233
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?
- ClinicalTrials.gov ID
- NCT00220688
- Acronym / sponsor ID
- SRC1
- Conditions
- Cancer
- Keywords
- nausea, vomiting, palliative, acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Oct 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting.
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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure Wristbands | Device | – |
Primary outcome
1.Visual Analogue Scale of nausea measured every 6 hours.
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Results publication: PubMed 1457233Brown 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. doi: 10.1177/104990919200900409.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Perkins, MB BCh MRCP principal investigator
Sue Ryder Care St. John's Hospice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure Wristbands in people with Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Visual Analogue Scale of nausea measured every 6 hours.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00220688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2009; AzTrials last refreshed its copy on 6 Nov 2026.