Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-18 @ 8:44 PM
Study NCT ID:
NCT03796195
Status:
TERMINATED
Last Update Posted:
2023-01-25
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'd-walega@northwestern.edu', 'phone': '3126952500', 'title': 'David Walega, MD', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was closed early for slow enrollment.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for 4 weeks after stellate ganglion block procedure.', 'description': 'Data obtained by telephone call up to 4 weeks post stellate ganglion block procedure.', 'eventGroups': [{'id': 'EG000', 'title': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)\n\n.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hot Flash Frequency Change Baseline to 3 Months After Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)\n\n.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.78', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months after SGB procedure', 'description': 'Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.', 'unitOfMeasure': 'Hot flashes/day', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)\n\n.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months after stellate ganglion block', 'description': 'The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.', 'unitOfMeasure': 'Score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)\n\n.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after stellate ganglion block', 'description': 'PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).', 'unitOfMeasure': 'Score on a scale', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change Score (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)\n\n.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after stellate ganglion block', 'description': 'The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).', 'unitOfMeasure': 'Score on a scale', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)\n\n.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study closed early', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)\n\n.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': '(kg/m^2)'}, {'title': 'Baseline Hot Flash-Related Daily Interference Scale (HFRDIS)', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'HFRIDS is a 10 question survey scored on a scale of 0=no interference and 10=high interference.\n\nQuestions inquire about work, social activities, leisure activities,sleep, mood,concentratoin, relationship with others, sexuality,enjoyment of life and overqll quality of life. Low score=0 is the lowest interference score and the highest interference score is 100.', 'unitOfMeasure': 'score on a scale'}, {'title': 'Baseline mean daily hot flashes', 'classes': [{'categories': [{'measurements': [{'value': '9.78', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline mean daily hot flashes reported by subject using daily diary.', 'unitOfMeasure': 'Hot flashes/day'}, {'title': 'PROMIS SF4a Sleep Score', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'PROMIS SF4a (sleep) Patient Reported Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality. sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).', 'unitOfMeasure': 'Score on a scale'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-16', 'size': 426004, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-13T18:49', 'hasProtocol': True}, {'date': '2020-09-16', 'size': 255569, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-13T18:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Enrollment issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2019-01-03', 'resultsFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2019-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-03', 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hot Flash Frequency Change Baseline to 3 Months After Treatment.', 'timeFrame': '3 months after SGB procedure', 'description': 'Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.'}], 'secondaryOutcomes': [{'measure': 'Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block', 'timeFrame': '3 months after stellate ganglion block', 'description': 'The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.'}, {'measure': 'PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.', 'timeFrame': '4 weeks after stellate ganglion block', 'description': 'PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).'}, {'measure': 'Patient Global Impression of Change Score (PGIC)', 'timeFrame': '4 weeks after stellate ganglion block', 'description': 'The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stelate Ganglion Block'], 'conditions': ['Prostate Cancer', 'Hot Flashes']}, 'referencesModule': {'references': [{'pmid': '29072790', 'type': 'BACKGROUND', 'citation': 'Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.'}, {'pmid': '28712786', 'type': 'BACKGROUND', 'citation': 'Dosani M, Morris WJ, Tyldesley S, Pickles T. The Relationship between Hot Flashes and Testosterone Recovery after 12 Months of Androgen Suppression for Men with Localised Prostate Cancer in the ASCENDE-RT Trial. Clin Oncol (R Coll Radiol). 2017 Oct;29(10):696-701. doi: 10.1016/j.clon.2017.06.009. Epub 2017 Jul 13.'}, {'pmid': '27294289', 'type': 'BACKGROUND', 'citation': "Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment. Psychol Health Med. 2017 Apr;22(4):425-433. doi: 10.1080/13548506.2016.1195504. Epub 2016 Jun 13."}, {'pmid': '11872028', 'type': 'BACKGROUND', 'citation': 'Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. doi: 10.1046/j.1464-4096.2001.01761.x. No abstract available.'}, {'pmid': '15379937', 'type': 'BACKGROUND', 'citation': 'Nishiyama T, Kanazawa S, Watanabe R, Terunuma M, Takahashi K. Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy. Int J Urol. 2004 Sep;11(9):735-41. doi: 10.1111/j.1442-2042.2004.00896.x.'}, {'pmid': '19962840', 'type': 'BACKGROUND', 'citation': 'Frisk J. Managing hot flushes in men after prostate cancer--a systematic review. Maturitas. 2010 Jan;65(1):15-22. doi: 10.1016/j.maturitas.2009.10.017. Epub 2009 Dec 4.'}, {'pmid': '23021559', 'type': 'BACKGROUND', 'citation': 'Trump DL. Commentary on "association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials." Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women\'s Hospital, 75 Francis Street, Boston, MA 02115, USA: JAMA 2011;306(21):2359-66. Urol Oncol. 2012 Sep;30(5):746-7. doi: 10.1016/j.urolonc.2012.06.007. No abstract available.'}, {'pmid': '27993906', 'type': 'BACKGROUND', 'citation': "Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, Sharp L. Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study. BMJ Open. 2016 Dec 19;6(12):e012952. doi: 10.1136/bmjopen-2016-012952."}, {'pmid': '23893467', 'type': 'BACKGROUND', 'citation': "Eziefula CU, Grunfeld EA, Hunter MS. 'You know I've joined your club... I'm the hot flush boy': a qualitative exploration of hot flushes and night sweats in men undergoing androgen deprivation therapy for prostate cancer. Psychooncology. 2013 Dec;22(12):2823-30. doi: 10.1002/pon.3355. Epub 2013 Jul 28."}]}, 'descriptionModule': {'briefSummary': 'Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life.\n\nStellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials.\n\nThe stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias.\n\nGiven the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Men with prostate cancer with bothersome hot flashes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months\n2. Age less than 65 years\n3. Body Mass Index (BMI) less than 32\n4. Willingness to undergo image guided intervention\n5. Greater than 28 hot flashes per week.\n\nExclusion Criteria:\n\n1. Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye)\n2. Current treatment of prostate cancer with radium or chemotherapy\n3. Use of treatments in the past two months that can affect HF (e.g., testosterone or androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and membrane stabilizers will be allowed but must be on stable unchanged dose for at least 8 weeks)\n4. Inability to write, speak, or read in English'}, 'identificationModule': {'nctId': 'NCT03796195', 'briefTitle': '(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'STU00208657'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '.5% Bupivacaine', 'description': 'Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)', 'interventionNames': ['Drug: .5% Bupivacaine']}], 'interventions': [{'name': '.5% Bupivacaine', 'type': 'DRUG', 'otherNames': ['Right sided stelate ganglion block (SGB)'], 'description': 'Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)', 'armGroupLabels': ['.5% Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'David Walega, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Walega', 'investigatorAffiliation': 'Northwestern University'}}}}