Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01025518
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2009-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle mass and muscle strength', 'timeFrame': '13 weeks'}], 'secondaryOutcomes': [{'measure': 'Functional capacity', 'timeFrame': '13 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Head and Neck Neoplasms', 'Resistance training', 'Muscle mass', 'Functional capacity'], 'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dahanca.dk', 'label': 'Danish Head and Neck Cancer Group'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether resistance training in combination with dietary supplementation is tolerable among head and neck cancer patients and to evaluate the possible effect on muscle mass, strength and functional capacity.', 'detailedDescription': 'Head and neck cancer patients experience a significant loss of muscle mass following radiotherapy treatment due to cachexia and dysphagia. This negatively affects muscle strength and functional capacity.\n\nStudies on healthy individuals and various groups of patients show that resistance training in combination with protein and creatine ingestion is an effective means of increasing muscle mass, strength and functional capacity.\n\nThus the aim is to investigate the following:\n\n* is resistance training and dietary supplements tolerable among head and neck cancer patients\n* the effect of the intervention on muscle mass, strength and functional capacity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* head and neck cancer patients (localized to the larynx, pharynx and oral cavity) treated with curative radiotherapy\n* complete loss of tumor\n* WHO performance status between 0-1 and expected ability to complete the training protocol\n* No parenteral feeding\n* above the age of 18\n* written concent\n\nExclusion Criteria:\n\n* other malignant diseases\n* pregnancy\n* undergoing systematic resistance training or creatin ingestion\n* Alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01025518', 'briefTitle': 'DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients', 'organization': {'class': 'NETWORK', 'fullName': 'Danish Head and Neck Cancer Group'}, 'officialTitle': 'A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients', 'orgStudyIdInfo': {'id': 'DAHANCA 25A'}, 'secondaryIdInfos': [{'id': 'CIRRO-IP010309', 'type': 'OTHER_GRANT', 'domain': 'CIRRO'}, {'id': 'Ethical Comittee: 20090181'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'resistance training and dietary supplement', 'interventionNames': ['Other: Resistance training', 'Dietary Supplement: Protein and creatine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Resistance training and placebo ingestion', 'description': '12 weeks of resistance training and placebo ingestion', 'interventionNames': ['Other: Resistance training', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Resistance training', 'type': 'OTHER', 'description': '12 weeks of resistance training in combination with protein and creatine or placebo ingestion', 'armGroupLabels': ['Resistance training and placebo ingestion', 'resistance training and dietary supplement']}, {'name': 'Protein and creatine', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['In2Zyme WP80 and In2Zyme Biodrive 1'], 'description': '30 g of protein with each training session, 5 g of creatine pr day', 'armGroupLabels': ['resistance training and dietary supplement']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrine', 'armGroupLabels': ['Resistance training and placebo ingestion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Region Midt', 'country': 'Denmark', 'facility': 'Dept. of Experimental Clinical Oncology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Dept. of Experimental Clinical Oncology', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Jens Overgaard, Professor, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'DAHANCA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Head and Neck Cancer Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Danish Center for Interventional Research in Radiation Oncology (CIRRO)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Jens Overgaard', 'investigatorAffiliation': 'Danish Head and Neck Cancer Group'}}}}