Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-06 @ 8:32 PM
Study NCT ID:
NCT01432067
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2011-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2011-09-08', 'studyFirstSubmitQcDate': '2011-09-09', 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPPB Score', 'timeFrame': '1 year', 'description': 'The main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.'}, {'measure': 'Cognitive skills', 'timeFrame': '2 years', 'description': 'MMS test, verbal fluency'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'IPAQ, QLQ-C30, ADL, performance status (ECOG)'}, {'measure': 'nutritional status', 'timeFrame': '2 years'}, {'measure': 'Walking distance over 6 minutes', 'timeFrame': 'inclusion, 6 months and 1 year'}, {'measure': 'isometric muscle strength measures of upper and lower limbs', 'timeFrame': '2 years', 'description': 'microfet2 test'}, {'measure': 'weight', 'timeFrame': '2 years'}, {'measure': 'SPPB score', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'geriatry', 'curative care', 'physical activity'], 'conditions': ['Cancer', 'Elderly Population']}, 'descriptionModule': {'briefSummary': 'The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.', 'detailedDescription': 'Long-term evolution of successful-treated older patients is not well-known except for survival. They seem more affected by physical than psychological problems. The combined effects of aging, cancer, and treatments on muscle function could have hindered their usual physical activity. Cancer is associated with frailty. Fried and coll have defined a frailty phenotype as a combination of 3 or more of 5 conditions: exhaustion, loss of weight, decreased muscle strength, slow gait speed and low physical activity. Frail subjects have a higher risk of physical or cognitive disability and death. An intervention able to prevent frailty is of great interest for the older cancer patient and their quality of life. An intervention consisting of phone-program in physical activity has been associated with a decrease in self-reported disability in five-year obese survivors from cancer.\n\nPatients will be randomized in two arms (1:1 ratio). Arm 1: Physical activity advices according to a program adapted to physical status of the patient assessed using SPPB (short physical performance battery) and the IPAQ questionnaire. A monthly phone support during one year will be performed by an adapted physical activity instructor and delivery of PNNS guide for subjects older than 55 y old. Arm 2: Delivery of PNNS guide for subjects older than 55 year old: recommendation of 1/2 hour physical activity of any kind.\n\nEach patient will be followed during 2 years: First visit (V1) will take place before treatment. The subsequent visits will take place at 3 months (V2), 6 months (V3), 1 year (V4), 18 months (V5) and 2 years (V6), in which patients will complete questionnaires (IPAQ, QLQ-C30, one day dietary intakes), have clinical examinations (weight, performance status/ ECOG) and will be tested for physical facilities (SPPB, micro-fet2). These evaluations will be completed by the MMS / Fluency tests and the covered distance during 6 minutes at V1, V3, and V4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 70 years old or older\n* Curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/ or radiotherapy\n* Patient with histologically proven lymphoma or carcinoma :\n\n * Colon, rectum or anal canal Cancer\n * Breast Cancer\n * Esophageal cancer\n * Otolaryngology Cancer\n * Kidney cancer\n * hepatocellular carcinoma\n * Stomach Cancer\n * Pancreatic cancer\n * Bile duct cancer\n * Ovarian Cancer\n * All lymphoma diffuse large B-cell and all peripheral T-cells lymphomas\n * All low-grade lymphoma: lymphocytes, lymphocytes and plasma cells, follicular, mantle, marginal zone (MALT and others)\n * Prostate cancer\n * Bladder Cancer\n * Lung cancer\n * adenocarcinoma of unknown primary origin compatible with previous quoted origin\n* Performance status (ECOG) \\<4\n* Patient who had given oral consent to participate in the study\n\nExclusion Criteria:\n\n* Palliative cares for cancer'}, 'identificationModule': {'nctId': 'NCT01432067', 'acronym': 'CAPADOGE', 'briefTitle': 'Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'orgStudyIdInfo': {'id': 'CHUBX 2010/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adaptated physical activity', 'description': 'Physical activity advices adaptated to physical status of patients', 'interventionNames': ['Other: Adapted physical activity']}, {'type': 'OTHER', 'label': 'Standard physical activity', 'description': 'Daily physical activities based on a standard guide', 'interventionNames': ['Other: Classic physical activities']}], 'interventions': [{'name': 'Adapted physical activity', 'type': 'OTHER', 'description': 'Physical activity advices according to a program adapted to physical status of the patient.', 'armGroupLabels': ['Adaptated physical activity']}, {'name': 'Classic physical activities', 'type': 'OTHER', 'description': 'Daily physical activities based on a standard guide', 'armGroupLabels': ['Standard physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux - Hôpital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Dax', 'country': 'France', 'facility': 'CH de Dax', 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret, CLCC Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges, Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'CH Mont de Marsan', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'CHU Bordeaux - hôpital Xavier Arnozan', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '51056', 'city': 'Reims', 'country': 'France', 'facility': 'Institut jean Godinot, CLCC Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '60309', 'city': 'Senlis', 'country': 'France', 'facility': 'Centre hospitalier de Senlis', 'geoPoint': {'lat': 49.20724, 'lon': 2.58661}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin CLCC Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU Nancy hôpital adulte du brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Isabelle BOURDEL MARCHASSON, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux, France'}, {'name': 'Adélaïde DOUSSAU, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Bordeaux, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}