Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-28 @ 7:09 PM
Study NCT ID:
NCT01669460
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in overall fatigue as measured by Bruera global fatigue severity scale.', 'timeFrame': 'Within 4 days after completion of intervention (28 days of Red Bull™)'}], 'secondaryOutcomes': [{'measure': 'Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)', 'timeFrame': 'Within 4 days after completion of intervention (28 days of Red Bull™)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fatigue']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed prostate cancer\n* Currently receiving LHRH-agonist therapy for greater than 6 months\n* Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale\n* Able to swallow Red Bull™ Sugar-Free Drink\n* Life expectancy of at least 1 year\n* Able to read and write in English\n* Willing to limit consumption of alcohol to one drink per day\n\nExclusion Criteria:\n\n* Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)\n* Myocardial infarction within past 6 months\n* Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders\n* Evidence of drug or alcohol abuse\n* Known hypersensitivity to caffeine\n* Known history of liver and kidney insufficiencies\n* Known contraindications to Red Bull™ use'}, 'identificationModule': {'nctId': 'NCT01669460', 'briefTitle': 'Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy', 'orgStudyIdInfo': {'id': '12-5041-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Red Bull™ Sugar-Free Drink', 'description': 'Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days', 'interventionNames': ['Other: Red Bull™ Sugar-Free Drink']}], 'interventions': [{'name': 'Red Bull™ Sugar-Free Drink', 'type': 'OTHER', 'description': 'Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days', 'armGroupLabels': ['Red Bull™ Sugar-Free Drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 1C1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Neil Fleshner, MD, FRCSC, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}