Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 11:42 PM
Study NCT ID:
NCT01540968
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition and Physical Exercise Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of a combined treatment of nutritional therapy and physical exercise in palliative cancer out-patients. The investigators hypothesize that this combined intervention consisting of an increased energy- and protein intake and physical exercise level improves quality of life (QoL), functional and clinical status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic lung cancer or gastrointestinal cancer\n* WHO performance status 0, 1 or 2\n* Able to walk at least 100 meters independently without crutches or walking frame assessed by the treating physician on the basis of the patient's history and physical condition\n* Receiving palliative treatment\n\nExclusion Criteria:\n\n* Enteral and/or parenteral nutrition within 1 month previous to study participation\n* History of ileus within one month\n* Known brain metastases or symptomatic bone metastases\n* Psychiatric disorder precluding understanding of information on trial related topics and giving informed consent.\n* Any serious underlying medical condition which could impair the ability of the patient to participate in the trial"}, 'identificationModule': {'nctId': 'NCT01540968', 'briefTitle': 'Nutrition and Physical Exercise Study', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Winterthur KSW'}, 'officialTitle': 'Influence of a Combined Intervention by Nutritional Support and Physical Exercise on Quality of Life in Cancer Out-patients Treated in Palliative Intention.', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2011-0447'}, 'secondaryIdInfos': [{'id': 'KFS-2833-08-2011', 'type': 'OTHER_GRANT', 'domain': 'Krebsforschung Schweiz / Krebsliga Schweiz'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition & physical exercise', 'interventionNames': ['Behavioral: Nutrition & physical exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Nutrition & physical exercise', 'type': 'BEHAVIORAL', 'description': 'Patients will be randomly assigned to intensive individual nutritional counselling including oral nutritional supplements and a specifically designed exercise program combining strength and balance training.', 'armGroupLabels': ['Nutrition & physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8401', 'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}], 'overallOfficials': [{'name': 'Peter E. Ballmer, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kantonsspital Winterthur KSW'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}