Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-03-17 @ 10:36 PM
Study NCT ID:
NCT00068458
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2003-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival TRaining for ENhancing Total Health (STRENGTH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], '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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002118', 'term': 'Calcium'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D005638', 'term': 'Fruit'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2003-09-10', 'studyFirstSubmitQcDate': '2003-09-10', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting', 'timeFrame': '6 months', 'description': 'Assess estimates of effect sizes and to ascertain potential feasibility of implementing a distance-medicine based diet-exercise program within the cooperative group setting.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['weight changes', 'depression', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer'], 'conditions': ['Breast Cancer', 'Depression', 'Weight Changes']}, 'referencesModule': {'references': [{'pmid': '18501061', 'type': 'RESULT', 'citation': 'Demark-Wahnefried W, Case LD, Blackwell K, Marcom PK, Kraus W, Aziz N, Snyder DC, Giguere JK, Shaw E. Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Clin Breast Cancer. 2008 Feb;8(1):70-9. doi: 10.3816/CBC.2008.n.005.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: A home-based exercise and/or diet program may improve the quality of life of breast cancer patients by preventing an increase in body fat and weight and a loss of lean body tissue.\n\nPURPOSE: This randomized phase II trial is studying the effectiveness of three home-based diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of exercise alone or combined with a modified diet as home-based interventions to prevent increases in body fat during adjuvant chemotherapy in women with stage I, II, or IIIA breast cancer.\n* Compare the efficacy of these regimens, in terms of reducing gains in adipose tissue, reducing losses in absolute amounts of lean body tissue, reducing gains in weight, influencing levels of biomarkers associated with the risk of breast cancer and/or other comorbid conditions, improving self-efficacy for exercise behaviors, reducing depression, and improving quality of life in these patients.\n* Compare the adherence rates to these regimens in these patients.\n* Determine the associations between study condition and adherence and change in endpoints in patients treated with these regimens.\n* Determine the feasibility of conducting home-based exercise and diet studies using the infrastructure of the cooperative group.\n\nOUTLINE: This is a pilot, randomized, multicenter study. Patients are stratified according to body mass index (no more than 25 kg/m\\^2 vs more than 25 kg/m\\^2), race (white vs non-white), and prior exercise history (vigorous exercise of at least 30 minutes, 3 times a week prior to diagnosis) (yes vs no). Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I (calcium-rich diet): Patients receive materials and counseling to promote a diet that contains ample amounts of calcium (1,200-2,500 mg/day).\n* Arm II (calcium-rich diet and exercise): Patients receive materials and counseling as in arm I and instruction and materials to promote strength training and endurance exercises.\n* Arm III (calcium-rich, high fruit and vegetable, low-fat diet and exercise): Patients receive materials and counseling as in arm II and materials and counseling to consume at least 5 servings of vegetables and fruit per day and limit fat intake to less than 20% of total calories.\n\nIn all arms, patients continue regimens for 6 months.\n\nMeasurements of body composition, weight, waist circumference, serum levels of insulin, insulin-like growth factor, sex hormone-binding globulin, and total cholesterol are obtained at baseline and 6 months.\n\nQuality of life, depression, diet composition, and physical activity are assessed at baseline and at 3 and 6 months.\n\nPatients are followed at 1 month.\n\nPROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study within 16 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n * Stage I, II, or IIIA\n* Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Female\n\nMenopausal Status\n\n* Premenopausal, defined as at least 1 of the following:\n\n * Less than 4 months since last menstrual period at diagnosis\n * Follicle-stimulating hormone level in the premenopausal range\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* No calcium-based kidney stones\n\nCardiovascular\n\n* No angina within the past 6 months\n* No myocardial infarction within the past 6 months\n* No abnormal MUGA and/or stress test\n\nOther\n\n* Not pregnant or nursing\n* Access to a telephone\n* Able to read and speak English\n* No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer\n* No history of hyperthyroidism or hypothyroidism\n* No paralysis\n* No osteoarthritis with uncontrolled joint pain that would preclude exercise\n* No diverticulitis\n* No serious medical or psychiatric illness that would preclude giving informed consent or completing study therapy or quality of life questionnaires\n* No medical condition that would interfere with body composition assessment\n* No medical condition for which unsupervised exercise is contraindicated\n* No medical condition for which a high vegetable and fruit diet or a calcium-rich diet is contraindicated\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* See Disease Characteristics\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* No prior bilateral oophorectomy\n* No prior amputation\n* No concurrent transverse rectus abdominis myocutaneous surgery\n* No concurrent surgery\n\nOther\n\n* No concurrent blood-thinners (e.g., coumadin or warfarin)'}, 'identificationModule': {'nctId': 'NCT00068458', 'briefTitle': 'Survival TRaining for ENhancing Total Health (STRENGTH)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Phase II Randomized Study to Assess the Feasibility of Distance Medicine Based Exercise and Dietary Approaches to Prevent Body Composition Change Occurring During Adjuvant Chemotherapy for Early Stage Breast Cancer', 'orgStudyIdInfo': {'id': 'U10CA081851', 'link': 'https://reporter.nih.gov/quickSearch/U10CA081851', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U10CA081851', 'link': 'https://reporter.nih.gov/quickSearch/U10CA081851', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: calcium diet', 'description': 'Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).', 'interventionNames': ['Dietary Supplement: Calcium-Rich Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Exercise + Calcium-Rich Diet', 'description': 'Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day).', 'interventionNames': ['Other: Arm 2: Exercise + Calcium-Rich Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise + Fruit & Vegetable, Low Fat + Calcium Diet', 'description': 'Dietary counseling + materials promoting strength training and aerobic activity + a diet that has \\< 20% of energy coming from fat and intakes of fruits and vegetables of \\> 5 servings/day + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.', 'interventionNames': ['Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet']}], 'interventions': [{'name': 'Calcium-Rich Diet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Calcium'], 'description': '1,200 - 2,500 mg/day. 6 month intervention', 'armGroupLabels': ['Arm 1: calcium diet']}, {'name': 'Arm 2: Exercise + Calcium-Rich Diet', 'type': 'OTHER', 'otherNames': ['Calcium'], 'description': 'Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.', 'armGroupLabels': ['Arm 2: Exercise + Calcium-Rich Diet']}, {'name': 'Exercise + Fruit & Vegetable, Low Fat + Calcium Diet', 'type': 'OTHER', 'otherNames': ['Calcium'], 'description': '1,200 - 2,500 Calcium intake per day. 6 month intervention period.', 'armGroupLabels': ['Exercise + Fruit & Vegetable, Low Fat + Calcium Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeastern Medical Oncology Center', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '27157-1030', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas - Eastside', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Edward G. Shaw, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}, {'name': 'Wendy Demark-Wahnefried, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Cancer Institute'}, {'name': 'Roger T. Anderson, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}