Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT00421902
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2007-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture Treatment for Hot Flashes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Acupuncture to pevent hot flushes'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2007-01-12', 'studyFirstSubmitQcDate': '2007-01-12', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief from the hot flashes as determined by the hot flashes scoring system.', 'timeFrame': '6 months', 'description': 'A Questionnaire was given to the patients to determine the relief of hot flashes'}]}, 'conditionsModule': {'keywords': ['Hot flashes, prostate cancer, acupuncture'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '20605360', 'type': 'DERIVED', 'citation': 'Ashamalla H, Jiang ML, Guirguis A, Peluso F, Ashamalla M. Acupuncture for the alleviation of hot flashes in men treated with androgen ablation therapy. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1358-63. doi: 10.1016/j.ijrobp.2010.01.025. Epub 2010 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks', 'detailedDescription': 'Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks. Acupuncture was done according to specific guidelines and mapping.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Treatment for prostate cancer using hormonal ablation therapy\n* Average of three or more hot flashes a day\n* Performance Status (Karnofsky ≥ 60)\n* Patients must be ≥ 18 years of age\n* No other clinically significant disease\n* Signed study-specific consent form prior to study entry\n\nExclusion Criteria:\n\n* Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study\n* Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks)\n* Skin infections\n* Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months."}, 'identificationModule': {'nctId': 'NCT00421902', 'briefTitle': 'Acupuncture Treatment for Hot Flashes Study', 'organization': {'class': 'OTHER', 'fullName': 'New York Presbyterian Brooklyn Methodist Hospital'}, 'officialTitle': 'Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study', 'orgStudyIdInfo': {'id': 'NYM # 325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Acupuncture of the patients', 'interventionNames': ['Procedure: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'Patients will be have acupuncture (with electro stimulation)', 'armGroupLabels': ['Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'NYP- Brooklyn Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Hani Ashamalla, MD, FCCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NY Methodist Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Presbyterian Brooklyn Methodist Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of Radiation Oncology Department', 'investigatorFullName': 'Hani Ashamalla, MD', 'investigatorAffiliation': 'New York Presbyterian Brooklyn Methodist Hospital'}}}}