Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-28 @ 9:50 PM
Study NCT ID:
NCT01495650
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2011-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2011-12-19', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective fatigue', 'timeFrame': 'At 18 months', 'description': 'Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'At 18 months', 'description': 'Quality of life is measured by the EORTC QLC-C30 questionnaire'}, {'measure': 'Anxiety/depressive symptoms', 'timeFrame': 'At 18 months', 'description': 'Anxiety/depressive symptoms is measured by the HADS questionnaire'}, {'measure': 'Physical activity level', 'timeFrame': 'At 18 months', 'description': 'Physical activity level is measured by the GPAQ questionnaire'}, {'measure': 'Muscular fatigue', 'timeFrame': 'At 18 months', 'description': 'Muscular fatigue is measured by Myotest'}, {'measure': 'Attention fatigue', 'timeFrame': 'At 18 months', 'description': 'Attention fatigue is measured usingt the TAP 2.2 software'}, {'measure': 'Body Mass Index', 'timeFrame': 'At 18 months', 'description': 'Body Mass Index is calculated using bodyweight and length measurements'}, {'measure': 'Body composition', 'timeFrame': 'At 18 months', 'description': 'Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Comprehensive Adjuvant Care', 'Cancer-related fatigue', 'Therapeutic patient education', 'Physical Activity', 'Nutritional counselling', 'Rehabilitation'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40064980', 'type': 'DERIVED', 'citation': 'Touraine C, Jacot W, Gourgou S, Carayol M, Senesse P, Ninot G, Mollevi C. Impact of adapted physical activity and diet counselling on health-related quality of life in women undergoing adjuvant breast cancer therapy. Sci Rep. 2025 Mar 10;15(1):8215. doi: 10.1038/s41598-025-91569-w.'}, {'pmid': '31345179', 'type': 'DERIVED', 'citation': 'Carayol M, Ninot G, Senesse P, Bleuse JP, Gourgou S, Sancho-Garnier H, Sari C, Romieu I, Romieu G, Jacot W. Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. BMC Cancer. 2019 Jul 25;19(1):737. doi: 10.1186/s12885-019-5896-6.'}]}, 'descriptionModule': {'briefSummary': 'Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.', 'detailedDescription': 'Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient with histologically proven breast cancer\n* 18-76 years old\n* Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + taxanes) followed by radiotherapy\n* Satisfactory healing of breast and lymph nodes area\n* Ability to understand the nature, goal and study methodology\n* Consent to cooperate for clinical assessments\n* Affiliation to a social security regime or beneficiary of equivalent social protection\n* Written informed consent provided before any study specific procedures\n\nExclusion Criteria:\n\n* HER2 positive or metastatic cancer\n* Any other primary tumor\n* Contraindication to moderate physical activity\n* Contraindication to adjuvant chemotherapy or radiotherapy\n* Pregnancy or breast feeding\n* Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial'}, 'identificationModule': {'nctId': 'NCT01495650', 'acronym': 'APAD', 'briefTitle': 'Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.', 'orgStudyIdInfo': {'id': 'APAD'}, 'secondaryIdInfos': [{'id': '2010-A00906-33', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'interventionNames': ['Behavioral: Tailored program of PA and nutritional counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Routine practice'}], 'interventions': [{'name': 'Tailored program of PA and nutritional counseling', 'type': 'BEHAVIORAL', 'description': 'Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "CRLC Val d'Aurelle-Paul Lamarque", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}