Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00244894
Status:
TERMINATED
Last Update Posted:
2017-04-28
First Post:
2005-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D019584', 'term': 'Hot Flashes'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2005-10-25', 'studyFirstSubmitQcDate': '2005-10-25', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment', 'timeFrame': 'Weeks 4 after initiation of study treatment.'}, {'measure': 'Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment', 'timeFrame': '10 Weeks after initiation of study treatment.'}, {'measure': 'Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 16 weeks after initiation of study treatment', 'timeFrame': '16 Weeks after initiation of study treatment.'}], 'secondaryOutcomes': [{'measure': 'Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 4 weeks after initiation of study treatment', 'timeFrame': '4 Weeks after initiation of study treatment.'}, {'measure': 'Change in biomarkers at baseline after initiation of study treatment', 'timeFrame': 'Baseline after initiation of study treatment.'}, {'measure': 'Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 10 weeks after initiation of study treatment', 'timeFrame': '10 weeks after initiation of study treatment.'}, {'measure': 'Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 16 weeks after initiation of study treatment', 'timeFrame': '16 Weeks after intiation of study treatment.'}, {'measure': 'Change in biomarkers at 4 weeks after initiation of study treatment', 'timeFrame': '4 Weeks after initiation of study treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fatigue', 'recurrent prostate cancer', 'stage II prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer', 'hot flashes'], 'conditions': ['Fatigue', 'Hot Flashes', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer.\n\nPURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes in patients with prostate cancer who are undergoing androgen deprivation.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the impact of acupuncture therapy on the frequency and intensity of hot flashes and the quality of life of patients with prostate cancer undergoing androgen deprivation.\n* Determine if blood serotonin and urinary 5-HIAA are increased in patients treated with acupuncture.\n* Determine if plasma calcitonin gene-related peptide and MHPG are reduced in patients with hot flashes due to androgen deprivation treated with acupuncture.\n* Determine the ability of tongue diagnosis, a traditional Chinese clinical assessment method, to predict clinical and biological changes in these patients.\n* Determine the effect of acupuncture on insomnia and loss of vitality caused by hot flashes in these patients.\n\nOUTLINE: Patients undergo acupuncture for 30 minutes twice weekly for 4 weeks and then once weekly for an additional 6 weeks.\n\nQuality of life is assessed at baseline, at weeks 2, 4, 6, and 10, and then at 6 weeks after completion of study treatment.\n\nAfter completion of study treatment, patients are followed at 6 weeks.\n\nPROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Confirmed diagnosis of prostate cancer\n* Hot flash score ≥ 4 per day\n* Prior or concurrent treatment with 1 of the following :\n\n * Bilateral orchiectomy\n * Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy\n * Antiandrogen therapy\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* No mental impairment\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy\n\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior estrogen or progestational drugs\n\nSurgery\n\n* See Disease Characteristics\n* No prior placement of a pacemaker or other implantable electrical device\n\nOther\n\n* More than 4 weeks since prior gabapentin\n* No concurrent antidepressant drugs'}, 'identificationModule': {'nctId': 'NCT00244894', 'briefTitle': 'Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Acupuncture for Hot Flashes in Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'CDR0000445180'}, 'secondaryIdInfos': [{'id': 'OHSU-7235'}, {'id': 'OHSU-HOR-02029-LX'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'acupuncture therapy', 'type': 'PROCEDURE', 'description': 'Acupuncture treatments will be administered by a qualified practitioner twice a week for the first four weeks and once per week for an additional 6 weeks. Sterile, disposable Seirin needles will be placed bilaterally at the point Gallbladder 34, and along the spine at Bladder 15, Bladder 23, and Bladder 32. Low intensity electrostimulation at 2 Hz will be used for both Bladder 23 and Bladder 32. Points will also be placed unilaterally at Governing vessel 20, Heart 7, Pericardium 6, Liver 2, and Spleen 6'}, {'name': 'fatigue assessment and management', 'type': 'PROCEDURE', 'description': 'Patients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper.'}, {'name': 'hot flashes attenuation', 'type': 'PROCEDURE', 'description': 'Patients will be asked to report hot flash frequency and severity daily using the hot flash diary (HFD) and hot flash severity guidelines (HFSG) throughout the treatment period.'}, {'name': 'management of therapy complications', 'type': 'PROCEDURE', 'description': "Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality."}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland VA Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Tomasz M. Beer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tom Beer', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}