Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT01881516
Status:
UNKNOWN
Last Update Posted:
2013-06-19
First Post:
2013-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue（CRF）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2013-06-13', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Fatigue Inventory, BFI', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'MDASI-C', 'timeFrame': '12 months'}, {'measure': 'number of adverse events of acupuncture', 'timeFrame': '24 months'}, {'measure': 'FACT-L', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Cancer Related Fatigue']}, 'descriptionModule': {'briefSummary': "we plan to conduct this trial to find out：\n\n* If acpuncture treatment could relieve CRF among lung cancer patients receiving chemo- or radio-therapy？\n* How about the extent it relieves？the safety and applicability ？\n* What's the possible influential factor and mechanism ？"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who are pathologically/cytologically diagnosed as NSCLC and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment;\n* Participants who meet the diagnosis criteria of CRF（ICD-10 criteria);\n* The first time to receive acupuncture treatment;\n* The age is between 18 and 65 years old;\n* Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above;\n* ECOG performance status 0, 1 or 2.\n* Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine \\< 2.0 mg/dL, Bilirubin \\< 1.5 mg/dL, ALT \\< 3 x normal, albumin \\>30g/L.\n* Have not taken any hypnotic, melatonin, or antidepressants within 30 days;\n* Willing to finish the whole observation period;\n* With written consent form signed by themselves.\n\nExclusion Criteria:\n\n* Participants in other clinical research;\n* Can not be pathologically or cytologically diagnosed as NSCLC;\n* ECOG 3\\~4;\n* Pregnant woman;\n* \\>65 or \\<18 years old;\n* Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue;\n* Patients who have received acupuncture ever before;\n* Received surgery, immunotherapy or target therapy within one month before the recruition；\n* Taking warfarin or heparin, a bleeding tendency exists;\n* Infection, ulceration or hyperalgesia at or near the local acupoints' skin，or with active infections；\n* There are cerebral vascular accident history or spinal cord injury history；\n* Combination with other serious diseases or condition, including congestive heart failure, Unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.;\n* Patients with a life expectancy \\< 3 months;\n* Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician."}, 'identificationModule': {'nctId': 'NCT01881516', 'briefTitle': 'Acupuncture Research on Lung Cancer Patients With Cancer Related Fatigue（CRF）', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Stage II Trial of Acupuncture For Lung Cancer Patients With Cancer Related Fatigue（CRF）', 'orgStudyIdInfo': {'id': 'CIM2013-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture', 'description': 'Participants will receive 30-min sessions of true acupuncture per week after randomization for 6 weeks', 'interventionNames': ['Device: acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham acupuncture', 'description': 'Participants will receive 30-min sessions of sham acupuncture per week after randomization for 6 weeks.', 'interventionNames': ['Device: sham acupuncture']}], 'interventions': [{'name': 'acupuncture', 'type': 'DEVICE', 'otherNames': ['Streitberger needles'], 'description': 'once per week for 6 weeks，30 mins for each treatment and for seven main acupoints', 'armGroupLabels': ['Acupuncture']}, {'name': 'sham acupuncture', 'type': 'DEVICE', 'otherNames': ['Park Sham Device'], 'description': 'the same acupoints and time as in acupuncture arm, but use a Park Sham Device', 'armGroupLabels': ['sham acupuncture']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'jing xie, MD', 'role': 'CONTACT', 'email': 'isable624@163.com', 'phone': '+86 021 64175590', 'phoneExt': '3625'}], 'overallOfficials': [{'name': 'jing xie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'zhen chen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fudan University'}, {'name': 'qiang zhi meng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending', 'investigatorFullName': 'xie jing', 'investigatorAffiliation': 'Fudan University'}}}}