Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-03-01 @ 5:17 PM
Study NCT ID:
NCT02619266
Status:
UNKNOWN
Last Update Posted:
2015-12-04
First Post:
2015-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000855', 'term': 'Anorexia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D019290', 'term': 'Megestrol Acetate'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008535', 'term': 'Megestrol'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-27', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Edmonton Symptom Assessment Scale', 'timeFrame': 'Baseline, the days 8 and 15.', 'description': 'Edmonton Symptom Assessment Scale is a nine-item patient-rated symptom visual analogue scale developed for use in assessing the symptoms of patients receiving palliative care.'}, {'measure': 'The Questionnaire of Acupuncture-related Events(QAE)', 'timeFrame': 'Baseline and the days 7', 'description': 'The side effects and their detail will be record during and after the acupuncture.'}], 'primaryOutcomes': [{'measure': 'Appetite Visual Analog Scale', 'timeFrame': 'Baseline, the days 8 and 15.', 'description': 'The assessment will be done thirty minutes before meals. The participators should record the score of their appetite (0 to 100 mm) the higher scores reflect better symptom control.'}], 'secondaryOutcomes': [{'measure': 'Council of Nutrition appetite questionnaire (CNAQ)', 'timeFrame': 'Baseline, the days 8 and 15.', 'description': 'Ask the subjects to complete the questionnaire by circling the correct answers and then tally the results based upon the following numerical scale: a =1, b = 2, c = 3, d = 4, e = 5. The sum of the scores for the individual items constitutes the CNAQ score. CNAQ score ≤28 indicates significant risk of at least 5% weight loss within six months.'}, {'measure': 'Caloric intake', 'timeFrame': 'Baseline, the days 8 and 15.', 'description': 'The caloric intake will be assessed by the dietician.'}, {'measure': 'Functional Assessment of Anorexia/Cachexia Therapy', 'timeFrame': 'Baseline, the days 8 and 15.', 'description': 'Functional Assessment of Anorexia/Cachexia Therapy was designed to measure general aspects of quality of life (QOL) as well as specific anorexia/cachexia-related concerns.'}, {'measure': 'Nutritional status', 'timeFrame': 'Baseline, the days 8 and 15.', 'description': 'weight was determined in kilograms. Triceps skinfold (mm), arm circumference(cm), and calf circumference (cm) were determined'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer Anorexia Cachexia Syndrome', 'Acupuncture', 'Megestrol acetate', 'Poor Appetite', 'Anorexia', 'Randomized Controlled Trial'], 'conditions': ['Anorexia', 'Cancer Cachexia']}, 'referencesModule': {'references': [{'pmid': '23439759', 'type': 'BACKGROUND', 'citation': 'Del Fabbro E, Dev R, Hui D, Palmer L, Bruera E. Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: a double-blind placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1271-6. doi: 10.1200/JCO.2012.43.6766. Epub 2013 Feb 25.'}, {'pmid': '12506181', 'type': 'BACKGROUND', 'citation': 'Bruera E, Strasser F, Palmer JL, Willey J, Calder K, Amyotte G, Baracos V. Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: a double-blind, placebo-controlled study. J Clin Oncol. 2003 Jan 1;21(1):129-34. doi: 10.1200/JCO.2003.01.101.'}, {'pmid': '2205358', 'type': 'BACKGROUND', 'citation': 'Bruera E, Macmillan K, Kuehn N, Hanson J, MacDonald RN. A controlled trial of megestrol acetate on appetite, caloric intake, nutritional status, and other symptoms in patients with advanced cancer. Cancer. 1990 Sep 15;66(6):1279-82. doi: 10.1002/1097-0142(19900915)66:63.0.co;2-r.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrials.gov/ct2/show/NCT02148159', 'label': 'Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer'}]}, 'descriptionModule': {'briefSummary': 'This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.', 'detailedDescription': 'Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed gastrointestinal tand lung cancers;\n2. Age ≥18 years;\n3. Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;\n4. Had a history of weight loss ≥5% within 6 moths;\n5. Maintained oral intake;\n6. Signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;\n2. Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;\n3. Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);\n4. Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)\n5. Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;\n6. Lifetime expected less than 3 months.'}, 'identificationModule': {'nctId': 'NCT02619266', 'briefTitle': 'The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'The Traditional Chinese Medicine Department of Xin Qiao Hospital', 'orgStudyIdInfo': {'id': '2014YLC32'}, 'secondaryIdInfos': [{'id': '2015CB554504', 'type': 'OTHER_GRANT', 'domain': 'National Program on Key Basic Research Project (973 Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture+Placebo', 'description': 'Acupuncture once daily for 7 days and Placebo tablet by mouth, twice a day for 7 days.', 'interventionNames': ['Other: Acupuncture', 'Drug: Placebo(Megestrol Acetate)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Megestrol Acetate+Sham acupuncture', 'description': 'Megestrol Acetate tablet 160mg by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .', 'interventionNames': ['Other: Sham Acupuncture', 'Drug: Megestrol Acetate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+Sham acupuncture', 'description': 'Placebo tablet by mouth, twice a day for 7 days and Sham Acupuncture once a day for 7 days .', 'interventionNames': ['Other: Sham Acupuncture', 'Drug: Placebo(Megestrol Acetate)']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'otherNames': ['Real acupuncture', 'True acupuncture'], 'description': 'Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.', 'armGroupLabels': ['Acupuncture+Placebo']}, {'name': 'Sham Acupuncture', 'type': 'OTHER', 'description': 'Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.', 'armGroupLabels': ['Megestrol Acetate+Sham acupuncture', 'Placebo+Sham acupuncture']}, {'name': 'Megestrol Acetate', 'type': 'DRUG', 'otherNames': ['Positive Drug'], 'description': 'Megestrol Acetate 160mg tablet', 'armGroupLabels': ['Megestrol Acetate+Sham acupuncture']}, {'name': 'Placebo(Megestrol Acetate)', 'type': 'DRUG', 'otherNames': ['Placebo Pill'], 'description': 'Starch pill manufactured to mimic Megestrol Acetate 160mg tablet', 'armGroupLabels': ['Acupuncture+Placebo', 'Placebo+Sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402760', 'city': 'Jiangbei', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Li, MD', 'role': 'CONTACT'}, {'name': 'Jing Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chongqing TCM Hospital', 'geoPoint': {'lat': 29.7283, 'lon': 106.63506}}, {'zip': '400037', 'city': 'Shapingba', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zihui Xu, PhD', 'role': 'CONTACT', 'email': 'zihuixu@yeah.net'}, {'name': 'Haiou Luo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'XinQiao Hosiptal'}, {'city': 'Shapingba', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong Li, MD', 'role': 'CONTACT', 'phone': '86+15023101890'}, {'name': 'Dong Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Donghua Hosiptal'}, {'zip': '400042', 'city': 'Yuzhong', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinglu Shan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Daping Hospital'}], 'centralContacts': [{'name': 'Zihui Xu, PhD', 'role': 'CONTACT', 'email': 'zihuixu@yeah.net', 'phone': '86-023-68755615'}, {'name': 'Ye Cui, MD', 'role': 'CONTACT', 'email': 'cuiyendian@163.com', 'phone': '86-023-68774249'}], 'overallOfficials': [{'name': 'Yong Tang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chengdu University of Traditional Chinese Medicine'}, {'name': 'Chaoting Zhao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xinqiao Hospital'}, {'name': 'Haiou Luo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinqiao Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director, Clinical Reseach', 'investigatorFullName': 'Chaoting Zhao', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}