Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-27 @ 2:20 AM
Study NCT ID:
NCT00039793
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Massage Therapy for Cancer-Related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland 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'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2004-03'}, 'lastUpdateSubmitDate': '2006-08-17', 'studyFirstSubmitDate': '2002-06-11', 'studyFirstSubmitQcDate': '2002-06-12', 'lastUpdatePostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Cancer-related fatigue', 'alternative medicine', 'cancer rehabilitation /care', 'fatigue', 'human therapy evaluation', 'physical therapy', 'neoplasm /cancer chemotherapy', 'neoplasm /cancer palliative treatment'], 'conditions': ['Breast Neoplasms', 'Ovarian Neoplasms', 'Prostatic Neoplasms', 'Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '18534330', 'type': 'DERIVED', 'citation': 'Patterson M, Maurer S, Adler SR, Avins AL. A novel clinical-trial design for the study of massage therapy. Complement Ther Med. 2008 Jun;16(3):169-76. doi: 10.1016/j.ctim.2007.08.001. Epub 2007 Sep 21.'}], 'seeAlsoLinks': [{'url': 'http://www.ucsf.edu/ocim/', 'label': 'Click here for more information about how to contact this study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.', 'detailedDescription': "The proposed project is a randomized pilot trial of a Swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. Fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. Massage therapy is a non-invasive intervention used in many patients with cancer for symptom control. Prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. Based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being.\n\nThe proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a Swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. Patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. This study will determine efficacy, functioning, perceptions of fatigue, and quality of life. This study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying CAM interventions for difficult-to-treat symptomatic conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Confirmed tissue diagnosis of cancer of the breast, ovary, prostate or colo-rectum\n* Have an anticipated completion of chemotherapy no more than 2 weeks before the last bodywork session.\n* Have a primary oncologist\n* Currently receiving chemotherapy or completed chemotherapy treatment within the past 6 months\n\nExclusion criteria:\n\n* Active skin rash or open cutaneous lesions.\n* History of venous thrombosis (or symptomatic varicosity)\n* Identification of a thrombosis using an ultrasound test of the legs.\n* Long term (\\> 3 months) steroid medications for other medical conditions in past 5 years\n* Plans to move out of the study region within 6 months\n* Thyroid-stimulating hormone (TSH) level above the upper limit of normal\n* Hematocrit \\<25%\n* Platelet count of \\< 50,000\n* Patients who have been receiving regular (i.e. at least twice a month) bodywork over the past 6 months.'}, 'identificationModule': {'nctId': 'NCT00039793', 'briefTitle': 'Massage Therapy for Cancer-Related Fatigue', 'nctIdAliases': ['NCT00058513'], 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Massage Therapy for Cancer-Related Fatigue', 'orgStudyIdInfo': {'id': 'R21AT000348-01', 'link': 'https://reporter.nih.gov/quickSearch/R21AT000348-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Moderate-intensity and low-intensity bodywork therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Osher Center for Integrative Medicine', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Andrew Avins, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco'}, {'name': 'Shelley Adler, PhD', 'affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco'}, {'name': 'Michael Patterson, MS', 'affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}