Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 7:37 PM
Study NCT ID:
NCT02068950
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2014-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressive Resistance Training Program 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'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscle biopsies', 'timeFrame': 'up to 7 months', 'description': 'In order to establish energy-reserves in the muscles'}, {'measure': 'Blood samples', 'timeFrame': 'Up to 20 months', 'description': 'In order to identify systemic factors released during exercise'}], 'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': 'up to 7 months', 'description': 'The feasibility outcomes will be inclusion rate defined as the number of patients recruited from the number of eligible patients and completion rate defined as the number of participants able to complete the intervention.\n\nAdherence to the exercise intervention will be evaluated via patient-reported training logs.'}], 'secondaryOutcomes': [{'measure': 'Change in LBM', 'timeFrame': 'up to 20 months', 'description': 'Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA).'}, {'measure': 'Weight loss', 'timeFrame': 'up to 20 months', 'description': 'Patient will be weighed weekly during the 12-week PRT program; afterwards at each follow-up (2, 5, 9, and 13 months)'}, {'measure': 'Number of patients with side-effects to treatment', 'timeFrame': 'up to 7 months', 'description': 'Side-effects will be registered using Common Terminology Criteria for Advers Events v4.0 (CTCAE).'}, {'measure': 'Quality of Life', 'timeFrame': 'Up to 20 months'}, {'measure': 'Change in physical function and strength', 'timeFrame': 'Up to 20 months', 'description': 'Change in muscle strength will be evaluated by 1 repetition maximum test (1RM) measured in kg.\n\nChange in muscle power will be evaluated by Nottingham Power Rig and measured in watts and watt/kg.\n\nChange in physical function will be evaluated by 30 second sit-to-stand test, arm curl test and stair climbing.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Head and neck cancer', 'Concurrent chemoradiotherapy', 'Progressive resistance training', 'Exercise', 'Feasibility', 'Weight loss', 'LBM', 'Body composition'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.', 'detailedDescription': '12 patients with head and neck cancer will be recruited to this trial. Entering a 12-week PRT program which will start one week before radiotherapy. The tested training program is a 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body. The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. This approach has previously been used for exercise interventions for lung cancer patients at our facility, and was highly appreciated by the patients.\n\nIn addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered on a weekly basis: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.\n\nPhysical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 2, 5, 9 and 13 months follow-up. At similar time points dual energy x-ray absorptiometry (DXA) scans for body composition will be performed using a Lunar iDXA (GE Healthcare).\n\nBlood samples will be drawn at baseline, an additional three times during the first 6 weeks and then weekly in relation to training sessions, and at 2, 5, 9 and 13 months follow-up.\n\nPatient reported quality of life (EORTC Quality of Life Questionaire (QLQ)-C30 and QLQ-H\\&N35) will be registered at baseline, after 12-weeks PRT and during 5 and 13 months follow-up.\n\nStudy duration is expected to be 7 months for the pilot-trial, with a follow-up of additional 13 months after the last patient has completed the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with head and neck squamous cell carcinoma\n* Candidates for concomitant chemoradiotherapy according to Danish Head and Neck Cancer Group (DAHANCA) guidelines.\n* Performance status 0-1\n* Expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance.\n* At least 18 years of age.'}, 'identificationModule': {'nctId': 'NCT02068950', 'briefTitle': 'Progressive Resistance Training Program in Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial', 'orgStudyIdInfo': {'id': 'HH1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Progressive resistance training', 'description': '12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand).', 'interventionNames': ['Behavioral: Progressive resistance training']}], 'interventions': [{'name': 'Progressive resistance training', 'type': 'BEHAVIORAL', 'description': 'A 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body will be tested. Details of the program: 12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)', 'armGroupLabels': ['Progressive resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Dept. of Oncology', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Julie Gehl, ph.d.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant, ph.d.', 'investigatorFullName': 'Julie Gehl', 'investigatorAffiliation': 'Herlev Hospital'}}}}