Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT00550251
Status:
UNKNOWN
Last Update Posted:
2018-05-04
First Post:
2007-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2007-10-25', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of PRN Doses of anti-emetics needed', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nausea', 'Vomiting', 'Emesis', 'Palliative', 'Terminal', 'Cancer'], 'conditions': ['Nausea', 'Vomiting']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAssessors and patients will both be blinded to whether they patients are receiving active or placebo bands.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have a diagnosis of advanced cancer with an estimated prognosis of less than 1 year but more than 3 days.\n2. 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.\n3. 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).\n4. Can be male or female patients but must be over the age of 18.\n5. Have signed a consent form prior to entering the study.\n6. If patients are taking corticosteroids the dosage should be stable for 3 days before and during the trial.\n7. Be thought to be well enough to complete the 3 day trial.\n\nExclusion criteria:\n\n1. Arm lymphoedema.\n2. Weakness, fatigue or confusion sufficient that patient is unable to take part.\n3. Previous history of acupuncture/acupressure for nausea or vomiting, or history of use of acupressure by a close relative.\n4. History of Parkinsonism or Parkinsonism on examination.\n5. Patients will not be enrolled if they are sharing a room with another patient taking part in the study.\n6. Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.'}, 'identificationModule': {'nctId': 'NCT00550251', 'briefTitle': 'Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study', 'organization': {'class': 'OTHER', 'fullName': 'Sue Ryder Care'}, 'officialTitle': 'Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study', 'orgStudyIdInfo': {'id': 'SRC2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupressure Bands', 'description': 'Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.', 'interventionNames': ['Device: Acupressure Wrist Bands (Sea-Bands)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Elasticated wrist bands without active bead.', 'interventionNames': ['Device: Placebo wristbands']}], 'interventions': [{'name': 'Acupressure Wrist Bands (Sea-Bands)', 'type': 'DEVICE', 'otherNames': ['Sea-Bands'], 'description': 'Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.', 'armGroupLabels': ['Acupressure Bands']}, {'name': 'Placebo wristbands', 'type': 'DEVICE', 'otherNames': ['Seaband Placebo'], 'description': 'Elasticated wrist bands without active bead.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GL53 0QJ', 'city': 'Cheltenham', 'state': 'Gloucestershire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Paul Perkins, MB BCh MRCP', 'role': 'CONTACT', 'email': 'paul.perkins@suerydercare.org', 'phone': '+441242230199'}, {'name': 'Paul Perkins, MB BCh MRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sue Ryder Care Leckhampton Court Hospice', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}], 'centralContacts': [{'name': 'Paul Perkins, MB BCh MRCP', 'role': 'CONTACT', 'email': 'paul.perkins@suerydercare.org', 'phone': '+44 1242 230199'}], 'overallOfficials': [{'name': 'Paul Perkins, MB Bch MRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sue Ryder Care Leckhampton Court Hospice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sue Ryder Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Palliative Medicine', 'investigatorFullName': 'Paul Perkins', 'investigatorAffiliation': 'Sue Ryder Care'}}}}