Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-03-04 @ 1:34 PM
Study NCT ID:
NCT00476203
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2007-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga Study in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D001835', 'term': 'Body Weight'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2007-05-17', 'studyFirstSubmitQcDate': '2007-05-17', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life, fatigue, and body weight', 'timeFrame': 'baseline, 6 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'waist and hip circumference', 'timeFrame': 'baseline, 6 months, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Yoga', 'Quality of Life', 'Obesity', 'Fatigue', 'Weight'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '21207071', 'type': 'RESULT', 'citation': 'Littman AJ, Bertram LC, Ceballos R, Ulrich CM, Ramaprasad J, McGregor B, McTiernan A. Randomized controlled pilot trial of yoga in overweight and obese breast cancer survivors: effects on quality of life and anthropometric measures. Support Care Cancer. 2012 Feb;20(2):267-77. doi: 10.1007/s00520-010-1066-8. Epub 2011 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.', 'detailedDescription': 'Women who are overweight or obese have a higher risk of breast cancer than normal weight women. Furthermore, women who are overweight or obese or gain weight after diagnosis have an increased risk of recurrence or dying from breast cancer compared with normal weight women. Yoga has been associated with reduced weight gain and weight loss in persons without cancer. However, no studies have tested whether yoga leads to less weight gain or weight loss in breast cancer patients. Both obesity and the sequelae of breast cancer therapy can result in reduced health-related quality of life and severe fatigue, which may also be favorably affected by yoga practice. The specific aims of the proposed trial are to examine, in women with Stage 0-IIIa breast cancer who are at least 3 months post primary treatment for their disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga intervention on health-related quality of life, fatigue, and body weight.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 21-75\n* Diagnosed with a primary breast cancer Stage 0-IIIa\n* Current tamoxifen or aromatase inhibitor use is allowed\n* At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)\n* BMI: 24 kg/m2 or greater (If Asian or Asian-American BMI: 23 kg/m2 or greater)\n* No contraindications to participating in a yoga program\n* Able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in English\n* Gives informed consent, agrees to be randomly assigned\n\nExclusion Criteria:\n\n* Plans to leave the study area within the follow-up period\n* Is pregnant or plans to become pregnant during the study period.\n* History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)\n* Has practiced yoga more than 1 time per month in the past six months.\n* Current use of medications likely to interfere with adherence to interventions or study outcomes\n* Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)'}, 'identificationModule': {'nctId': 'NCT00476203', 'acronym': 'Yoga', 'briefTitle': 'Yoga Study in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study', 'orgStudyIdInfo': {'id': 'PHS - 6434'}, 'secondaryIdInfos': [{'id': 'U54CA116847-01', 'link': 'https://reporter.nih.gov/quickSearch/U54CA116847-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Immediate yoga classes offered', 'interventionNames': ['Behavioral: Yoga']}, {'type': 'OTHER', 'label': '2', 'description': 'Delayed yoga classes (after 6 months) offered \\[wait list control group\\]', 'interventionNames': ['Other: Delayed yoga classes']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': 'Instructor-led yoga classes 1/time per week + 4 days of home practice', 'armGroupLabels': ['1']}, {'name': 'Delayed yoga classes', 'type': 'OTHER', 'description': 'Delayed yoga classes (after 6 months) offered \\[wait list control group\\]', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Alyson Littman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Epidemiology, UW'}, {'name': 'Anne McTiernan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Mark Boyer, Director of Sponsored Research', 'oldOrganization': 'Fred Hutchinson Cancer Research Center'}}}}