Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00070967
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture to Improve Quality of Life in Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2005-02'}, 'lastUpdateSubmitDate': '2006-08-17', 'studyFirstSubmitDate': '2003-10-09', 'studyFirstSubmitQcDate': '2003-10-10', 'lastUpdatePostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acupuncture', 'Quality of Life', 'Complementary Therapies', 'TCM', 'Traditional Chinese Medicine'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This study will test the feasibility of acupuncture as a complementary therapy for advanced cancer by comparing symptoms and quality of life before and after 8 weeks of acupuncture treatments.', 'detailedDescription': "A large percentage of the practice and use of complementary and alternative medicine (CAM) in the United States is focused on cancer. Whether the CAM use is aimed at reducing one's risk of developing cancer or improving the quality of life of a cancer patient during treatment or at the end of life, the public focus on CAM and cancer has created a driving force for cancer centers to address the efficacy and science of these methods.\n\nCurrently, the majority of cancer patients do not receive adequate palliative care. Acupuncture has been shown to be effective in the treatment of pain and nausea and has also been shown to improve one's general well-being. Acupuncture also has some effectiveness in relieving symptoms of anxiety and depression. This study will evaluate the efficacy of acupuncture by Traditional Chinese Medicine clinicians to address the quality of life and symptoms of patients with incurable cancer.\n\nWomen with recurrent metastatic ovarian cancer and similar patients with advanced cancer who are ambulatory and receiving conventional palliative care will be enrolled in this study. Patients will continue to receive high-quality, conventional clinical interventions, including chemotherapy and pain and symptom reduction programs. Patients will also receive 8 weeks of acupuncture. Evaluation tools such as Satisfaction with Life Domains Scale for Cancer (SLDS-C), Brief Pain Inventory, and Rotterdam Symptom Check List will be used to assess the acupuncture intervention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Advanced cancer patients, primarily ovarian cancer patients\n* Undergoing palliative care treatment\n* Ambulatory\n* Symptomatic with pain, nausea, and/or an inadequate quality of life\n* Platelets \\> 25,000/mm3\n* ANC \\> 500 cells/mm3\n\nExclusion Criteria\n\n* Acupuncture treatment during the 6 months prior to study entry\n* History of bleeding disorder, such as hemophilia or von Willebrand disease\n* Acute psychosis'}, 'identificationModule': {'nctId': 'NCT00070967', 'briefTitle': 'Acupuncture to Improve Quality of Life in Patients With Advanced Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Effects of Acupuncture on Pain, Nausea, Quality of Life', 'orgStudyIdInfo': {'id': 'R21AT001010-01', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001010-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David S. Rosenthal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}