Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-22 @ 6:03 PM
Study NCT ID:
NCT01980160
Status:
WITHDRAWN
Last Update Posted:
2015-10-02
First Post:
2013-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Did not receive IRB approval from our institution therefore the study was closed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of episodes of Vomiting', 'timeFrame': '1 month', 'description': 'The primary outcome measure we are looking for is the number of vomiting episodes in patients with active wrist bands verse the sham wrist bands.'}, {'measure': 'Severity of Nausea', 'timeFrame': '1 month', 'description': 'One of the primary outcomes we are investigating is the severity of nausea in patients with active wrist bands verse the sham wrist bands.'}], 'secondaryOutcomes': [{'measure': 'Acute Emetic Episodes', 'timeFrame': '1 day', 'description': 'More specifically, the number of episodes of vomiting on Day 1.'}, {'measure': 'Severity of nausea', 'timeFrame': '1 day', 'description': 'The severity of acute nausea on day 1 of treatment.'}, {'measure': 'Delayed severe nausea', 'timeFrame': '5 days', 'description': 'The delayed number severe nausea episodes on days 2-5.'}, {'measure': 'Delayed emetic episodes', 'timeFrame': '5 days', 'description': 'Looking at the number of delayed emetic episodes during days 2-5 of treatment.'}, {'measure': 'Rescue Medication Use', 'timeFrame': '1 month', 'description': 'Will look at the use of rescue medication throughout treatment.'}]}, 'conditionsModule': {'conditions': ['Nausea', 'Vomiting']}, 'referencesModule': {'references': [{'pmid': '8777177', 'type': 'BACKGROUND', 'citation': 'Griffin AM, Butow PN, Coates AS, Childs AM, Ellis PM, Dunn SM, Tattersall MH. On the receiving end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol. 1996 Feb;7(2):189-95. doi: 10.1093/oxfordjournals.annonc.a010548.'}, {'pmid': '9257427', 'type': 'BACKGROUND', 'citation': 'Osoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J. Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer. 1997 Jul;5(4):307-13. doi: 10.1007/s005200050078.'}, {'pmid': '1299465', 'type': 'BACKGROUND', 'citation': "Lindley CM, Hirsch JD, O'Neill CV, Transau MC, Gilbert CS, Osterhaus JT. Quality of life consequences of chemotherapy-induced emesis. Qual Life Res. 1992 Oct;1(5):331-40. doi: 10.1007/BF00434947."}, {'pmid': '6840017', 'type': 'BACKGROUND', 'citation': 'Laszlo J. Nausea and vomiting as major complications of cancer chemotherapy. Drugs. 1983 Feb;25 Suppl 1:1-7. doi: 10.2165/00003495-198300251-00002.'}, {'pmid': '11251007', 'type': 'BACKGROUND', 'citation': 'Campos D, Pereira JR, Reinhardt RR, Carracedo C, Poli S, Vogel C, Martinez-Cedillo J, Erazo A, Wittreich J, Eriksson LO, Carides AD, Gertz BJ. Prevention of cisplatin-induced emesis by the oral neurokinin-1 antagonist, MK-869, in combination with granisetron and dexamethasone or with dexamethasone alone. J Clin Oncol. 2001 Mar 15;19(6):1759-67. doi: 10.1200/JCO.2001.19.6.1759.'}, {'pmid': '9818697', 'type': 'BACKGROUND', 'citation': 'Birch R, Weaver CH, Carson K, Buckner CD. A randomized trial of once vs twice daily administration of intravenous granisetron with dexamethosone in patients receiving high-dose cyclophosphamide, thiotepa and carboplatin. Bone Marrow Transplant. 1998 Oct;22(7):685-8. doi: 10.1038/sj.bmt.1701412.'}, {'pmid': '9917226', 'type': 'BACKGROUND', 'citation': 'Navari RM, Reinhardt RR, Gralla RJ, Kris MG, Hesketh PJ, Khojasteh A, Kindler H, Grote TH, Pendergrass K, Grunberg SM, Carides AD, Gertz BJ. Reduction of cisplatin-induced emesis by a selective neurokinin-1-receptor antagonist. L-754,030 Antiemetic Trials Group. N Engl J Med. 1999 Jan 21;340(3):190-5. doi: 10.1056/NEJM199901213400304.'}, {'pmid': '11105182', 'type': 'BACKGROUND', 'citation': 'Shen J, Wenger N, Glaspy J, Hays RD, Albert PS, Choi C, Shekelle PG. Electroacupuncture for control of myeloablative chemotherapy-induced emesis: A randomized controlled trial. JAMA. 2000 Dec 6;284(21):2755-61. doi: 10.1001/jama.284.21.2755.'}, {'pmid': '12836088', 'type': 'BACKGROUND', 'citation': 'Treish I, Shord S, Valgus J, Harvey D, Nagy J, Stegal J, Lindley C. Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy. Support Care Cancer. 2003 Aug;11(8):516-21. doi: 10.1007/s00520-003-0467-3. Epub 2003 Jun 27.'}, {'pmid': '10561376', 'type': 'BACKGROUND', 'citation': 'Gralla RJ, Osoba D, Kris MG, Kirkbride P, Hesketh PJ, Chinnery LW, Clark-Snow R, Gill DP, Groshen S, Grunberg S, Koeller JM, Morrow GR, Perez EA, Silber JH, Pfister DG. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol. 1999 Sep;17(9):2971-94. doi: 10.1200/JCO.1999.17.9.2971. No abstract available.'}, {'pmid': '10984871', 'type': 'BACKGROUND', 'citation': 'Oyama H, Kaneda M, Katsumata N, Akechi T, Ohsuga M. Using the bedside wellness system during chemotherapy decreases fatigue and emesis in cancer patients. J Med Syst. 2000 Jun;24(3):173-82. doi: 10.1023/a:1005591626518.'}, {'pmid': '22488022', 'type': 'BACKGROUND', 'citation': 'Wickham R. Evolving treatment paradigms for chemotherapy-induced nausea and vomiting. Cancer Control. 2012 Apr;19(2 Suppl):3-9. doi: 10.1177/107327481201902s02.'}, {'pmid': '17715696', 'type': 'BACKGROUND', 'citation': 'Schwartzberg LS. Chemotherapy-induced nausea and vomiting: which antiemetic for which therapy? Oncology (Williston Park). 2007 Jul;21(8):946-53; discussion 954, 959, 962 passim.'}, {'pmid': '11283143', 'type': 'BACKGROUND', 'citation': 'Sigsgaard T, Herrstedt J, Handberg J, Kjaer M, Dombernowsky P. Ondansetron plus metopimazine compared with ondansetron plus metopimazine plus prednisolone as antiemetic prophylaxis in patients receiving multiple cycles of moderately emetogenic chemotherapy. J Clin Oncol. 2001 Apr 1;19(7):2091-7. doi: 10.1200/JCO.2001.19.7.2091.'}, {'pmid': '11079280', 'type': 'BACKGROUND', 'citation': 'Herrington JD, Kwan P, Young RR, Lagow E, Lagrone L, Riggs MW. Randomized, multicenter comparison of oral granisetron and oral ondansetron for emetogenic chemotherapy. Pharmacotherapy. 2000 Nov;20(11):1318-23. doi: 10.1592/phco.20.17.1318.34894.'}, {'pmid': '9833299', 'type': 'BACKGROUND', 'citation': 'Osowski CL, Dix SP, Lynn M, Davidson T, Cohen L, Miyahara T, Sexauer MC, Joyce R, Yeager A, Wingard JR. An open-label dose comparison study of ondansetron for the prevention of emesis associated with chemotherapy prior to bone marrow transplantation. Support Care Cancer. 1998 Nov;6(6):511-7. doi: 10.1007/s005200050206.'}]}, 'descriptionModule': {'briefSummary': 'The primary study hypotheses are that, without increasing doses of breakthrough medications or device intolerance, the Nometex™ device worn for 5-days beginning with the day of chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce the severity of nausea.\n\nThe secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes, day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without increasing doses of breakthrough medications or device intolerance.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer\n2. Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion\n3. 18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center\n4. ECOG Status of 0-2\n5. Standardized Antiemetic Regimen\n\nExclusion Criteria:\n\n1. Pre-existing or at-risk for a peripheral neuropathy in region of device placement\n2. Implanted cardiac pace maker\n3. Nickel or other metal allergies\n4. Previous experience with median nerve/P6 stimulation\n5. Receiving concurrent radiation therapy\n6. Previous participants of this study will be excluded from future participation in this study.'}, 'identificationModule': {'nctId': 'NCT01980160', 'briefTitle': 'Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Randomized Single-Blind Study of Nometex as an Adjunct to Standard Anti-emetics in Ovarian and Advanced Endometrial and Cervical Cancer Patients Who Receive Moderately to Highly Emetogenic Chemotherapy', 'orgStudyIdInfo': {'id': 'NMT-Nometex'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Activated Nometex Device', 'description': 'Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.', 'interventionNames': ['Device: Activated Nometex Device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Unactivated Nometex Device', 'description': 'The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.', 'interventionNames': ['Device: Unactivated Nometex Device']}], 'interventions': [{'name': 'Activated Nometex Device', 'type': 'DEVICE', 'description': 'Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.', 'armGroupLabels': ['Activated Nometex Device']}, {'name': 'Unactivated Nometex Device', 'type': 'DEVICE', 'otherNames': ['Patients using this device will be given an unactivated Nometex device. It should be the same in appearance as the activated device.'], 'armGroupLabels': ['Unactivated Nometex Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F. Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neurowave Medical Technologies', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}