Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT00425906
Status:
WITHDRAWN
Last Update Posted:
2016-01-12
First Post:
2007-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000855', 'term': 'Anorexia'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No patient enrollment occurred.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2007-01-19', 'studyFirstSubmitQcDate': '2007-01-19', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of whether ≥ 50% of patients utilize nicotine for treating "hunger pain" ≥ 2 times over a 48-hour period', 'timeFrame': '48 Hours'}], 'secondaryOutcomes': [{'measure': 'Toxicity as measured by CTCAE v 2.0', 'timeFrame': '48 hours'}, {'measure': 'Global quality of life', 'timeFrame': '48 hours'}, {'measure': 'Hunger assessment', 'timeFrame': '48 hours'}, {'measure': 'Change in circulating hormonal concentrations (for patients enrolled at the Mayo Rochester Clinic only)', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psychosocial effects of cancer and its treatment', 'unspecified adult solid tumor, protocol specific', 'constipation, impaction, and bowel obstruction', 'anorexia', 'pain'], 'conditions': ['Anorexia', 'Constipation, Impaction, and Bowel Obstruction', 'Pain', 'Psychosocial Effects of Cancer and Its Treatment', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: The use of a nicotine inhaler may help decrease appetite and relieve "hunger pain" (an intense craving for food) in patients with malignant bowel obstruction caused by cancer.\n\nPURPOSE: This randomized clinical trial is studying the side effects and how well a nicotine inhaler works in treating "hunger pain" in patients with malignant bowel obstruction caused by cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether patients with malignant bowel obstruction due to incurable cancer utilize a potential therapy for "hunger pain."\n* Determine, preliminarily, the efficacy and toxicity of nicotine in treating "hunger pain" in these patients.\n* Determine whether nicotine results in a decline in circulating ghrelin (for patients enrolled at the Mayo Rochester Clinic only).\n* Evaluate hormonal changes in patients treated with nicotine (for patients enrolled at the Mayo Rochester Clinic only).\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter, pilot study. Patients are stratified according to vomiting status within the past 24 hours (yes vs no) and use of narcotics (yes vs no). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive a nicotine inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity .\n* Arm II: Patients receive a placebo inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity.\n\nAfter 48 hours, patients in arm I may continue nicotine therapy off study. Patients in arm II who are not surgical candidates may cross over to treatment with the nicotine inhaler off study.\n\nBlood and spot urine samples are collected at baseline and after 48 hours from patients enrolled at the Mayo Rochester Clinic. Blood samples are analyzed to evaluate circulating hormone (e.g., ghrelin, leptin) concentrations. Urine samples are analyzed to evaluate nicotine and nicotine metabolite concentrations.\n\nGlobal quality of life is assessed at baseline and after 48 hours. "Hunger pain" is assessed at baseline.\n\nPROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of any incurable malignancy\n* Presence of malignant bowel obstruction\n* Must be on strict "nothing per os" (NPO) status over the next 48 hours\n\n * Ice chips allowed\n* Acknowledges that "hunger pain" is a problem\n\nPATIENT CHARACTERISTICS:\n\n* Mentally competent\n* No history of life-threatening arrhythmia\n* No severe or worsening angina\n* No accelerated hypertension\n* No known hypersensitivity to nicotine\n* Not pregnant or nursing\n* Negative pregnancy test\n\nPRIOR CONCURRENT THERAPY:\n\n* Concurrent short-term use of dexamethasone or other hormonal therapy or symptom control strategy allowed'}, 'identificationModule': {'nctId': 'NCT00425906', 'briefTitle': 'Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer', 'orgStudyIdInfo': {'id': 'CDR0000526182'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': 'MC03C2', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '1217-03', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotine inhaler', 'interventionNames': ['Drug: nicotine', 'Procedure: Quality of life']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo inhaler', 'interventionNames': ['Other: Placebo', 'Procedure: Quality of life']}], 'interventions': [{'name': 'nicotine', 'type': 'DRUG', 'armGroupLabels': ['Nicotine inhaler']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo inhaler']}, {'name': 'Quality of life', 'type': 'PROCEDURE', 'armGroupLabels': ['Nicotine inhaler', 'Placebo inhaler']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aminah Jatoi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}, {'name': 'Gerardo Colon-Otero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Aminah Jatoi, M.D.', 'oldOrganization': 'Mayo Clinic'}}}}