Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-01 @ 8:44 AM
Study NCT ID:
NCT02510066
Status:
UNKNOWN
Last Update Posted:
2015-07-28
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-07-27', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores, assessed with numeric rating scale (NRS)', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'Karnofsky performance status (KPS) score', 'timeFrame': '1 week'}, {'measure': 'Blood levels of β-endorphin', 'timeFrame': '1 week'}, {'measure': 'Blood levels of nerve growth factor', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Pain', 'Acupuncture'], 'conditions': ['Pancreatic Cancer', 'Pain']}, 'descriptionModule': {'briefSummary': 'This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic cancer pain and then investigates its potential mechanism of peripheral blood.', 'detailedDescription': 'Acupuncture may alleviate abdominal or back pain of patients with advanced pancreatic cancer. Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week. Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. Pain scores on numeric rating scale (NRS) and blood levels of β-endorphin and nerve growth factor are compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced pancreatic cancer at Ⅲ-Ⅳ stage diagnosed by histological/cytological examination.\n* Pain score of abdominal or back pain ≥3 on a numeric rating scale (NRS) graduated from 0 to 10.\n* Stable dose of analgesics at least 72 hours before randomization.\n* Expected survival time more than 1 month.\n\nExclusion Criteria:\n\n* Another cause for abdominal or back pain (such as prolapse of lumbar intervertebral disc, ulcer or other intra-abdominal disorder).\n* Acupuncture treatment in the past.\n* Contraindications for the use of acupuncture (such as severe allergies, bleeding tendency, infectious dermatosis and ulcer or scar at points).\n* Unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT02510066', 'briefTitle': 'Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Cancer Hospital, China'}, 'officialTitle': 'Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain: : a Randomized, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '12401905600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week.', 'interventionNames': ['Device: Acupuncture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo acupuncture', 'description': 'Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period.', 'interventionNames': ['Device: Placebo acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'DEVICE', 'otherNames': ['Electroacupuncture'], 'description': "Disposable stainless steel filiform needles (40mm in length and 0.30mm in diameter) are inserted perpendicularly into T8-T12 Jiaji (Ex-B2) points bilaterally to a depth of 25 mm. After De Qi sensation is achieved, the handles of needles on homolateral T8 and T12 Jiaji are respectively connected to the Han's acupoint nerve stimulator at a frequency of 2/100 Hz and a current of 1mA with a disperse-dense waveform for 30 minutes.", 'armGroupLabels': ['Acupuncture']}, {'name': 'Placebo acupuncture', 'type': 'DEVICE', 'description': 'Placebo acupuncture needles (Dongbang AcuPrime Acupuncture Inc., South Korea) are used on the non-point points at the same level as T8 and T12 Jiaji, 4.5 cun lateral to the posterior median line. The needles with blunt tips are quickly put onto points without inserting into the skin. The needles on homolateral points at the same level as T8 and T12 Jiaji are then connected to the electric stimulator, but with zero frequency and electric current.', 'armGroupLabels': ['Placebo acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Chen', 'role': 'CONTACT', 'email': 'chengkll@sina.com', 'phone': '86-13601996751'}], 'facility': 'Shanghai Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hao Chen', 'role': 'CONTACT', 'email': 'chengkll@sina.com', 'phone': '86-13601996751'}], 'overallOfficials': [{'name': 'Hao Chen', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Cancer Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}