Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 10:09 AM
Study NCT ID:
NCT01492569
Status:
WITHDRAWN
Last Update Posted:
2013-06-12
First Post:
2011-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D012512', 'term': 'Sarcoma, Ewing'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-11', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of episodes of vomiting', 'timeFrame': 'During the first 24 hours of chemotherapy'}, {'measure': 'Severity of nausea as recorded on the visual analogue scale (VAS)', 'timeFrame': 'During the first 24 hours of chemotherapy', 'description': 'Measured as a continuous variable for the mean episodes of emesis. The mean VAS nausea score will also be measured as a continuous variable. Measured using the Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool.'}], 'secondaryOutcomes': [{'measure': 'Number of as needed (PRN) antiemetic medications needed', 'timeFrame': 'After the first 24 hours of chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Childhood Acute Lymphoblastic Leukemia', 'Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies', 'Ewing Sarcoma', 'Vomiting in Infants and/or Children', 'Osteosarcoma']}, 'descriptionModule': {'briefSummary': 'This randomized pilot clinical trial studies giving acupuncture in reducing nausea and vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.\n\nARM II: Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with a planned admission for at least 24 hours for highly emetogenic or moderately emetogenic chemotherapy at Lucile Packard Children's Hospital or Packard El Camino.\n* Planned to undergo at least 2 more cycles of chemotherapy.\n* Can include but not limited to: children with high risk ALL, AML, Ewing's Sarcoma, Osteosarcoma\n* History of vomiting with prior cycles of chemotherapy (2 episodes of emesis at minimum) despite use of conventional antiemetic medications.\n* Age 8-21.\n* Parent must be able to understand and willing to sign written informed consent document.\n\nExclusion Criteria:\n\n* Prior knowledge of acupuncture or experience with acupuncture or acupressure.\n* There will be no restrictions regarding use of other Investigational Agents.\n* Comorbid Diseases:\n\n * Diagnosis of any cardiac condition (cardiomyopathy, arrhythmia, pacemaker placement).\n * Any diagnosis requiring pediatric intensive care unit admission.\n * Patients with brain tumor, brain metastasis (these patients often require radiation and surgery in addition to chemotherapy which may confound the results)\n * Concomitant radiation therapy during current chemotherapy cycle.\n * Developmental delay patients with allergy to tape or leads will be excluded from the study.\n* Pregnant patients will be excluded from the study.\n* Cancer survivors will not be excluded from the study as long as they are undergoing chemotherapy treatment for their current cancer therapy.\n* HIV-positive patients will not be excluded."}, 'identificationModule': {'nctId': 'NCT01492569', 'briefTitle': 'Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting', 'orgStudyIdInfo': {'id': 'PEDSVAR0016'}, 'secondaryIdInfos': [{'id': 'NCI-2011-03653', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (TAPS at the P6 point)', 'description': 'Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.', 'interventionNames': ['Other: questionnaire administration', 'Procedure: electroacupuncture therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Arm II (TAPS at a non-P6 point)', 'description': 'Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.', 'interventionNames': ['Procedure: electroacupuncture therapy', 'Other: questionnaire administration']}], 'interventions': [{'name': 'electroacupuncture therapy', 'type': 'PROCEDURE', 'otherNames': ['electroacupuncture'], 'description': 'Undergo TAPS at sham point', 'armGroupLabels': ['Arm II (TAPS at a non-P6 point)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (TAPS at the P6 point)', 'Arm II (TAPS at a non-P6 point)']}, {'name': 'electroacupuncture therapy', 'type': 'PROCEDURE', 'otherNames': ['electroacupuncture'], 'description': 'Undergo TAPS', 'armGroupLabels': ['Arm I (TAPS at the P6 point)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Brenda Golianu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}