Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04554667
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2020-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heavy Lifting Strength Training in Head and Neck Cancer Survivors
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'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, safety and feasibility trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': 'Over 12 weeks', 'description': 'Recruitment rate (with reasons for refusal).\n\nRecruitment minimum: 15 participants Recruitment maximum: 20 participants Higher number= better and more data'}, {'measure': 'Muscular Strength', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Change in muscular strength from baseline to postintervention with be assessed using maximal strength tests.\n\nMinimum: none Maximum: none Higher score= better strength'}, {'measure': 'Program Adherence', 'timeFrame': 'Over 12 weeks', 'description': 'Program adherence minimum: 80% Program adherence maximum: 100% Higher score= better adherence'}], 'secondaryOutcomes': [{'measure': 'Physical functioning', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using the Neck Dissection Impairment Index (NDII) and maximum strength tests.\n\nMinimum: 40 Maximum: 100 Higher score= worse impairment'}, {'measure': 'Fear of cancer recurrence', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using the Fear of Cancer Recurrence Inventory (FCRI)\n\nMinimum: 0 Maximum: 36 Higher score= worse fear of cancer recurrence'}, {'measure': 'Post Traumatic Growth after cancer', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': "How cancer has changed an individual's life will be assessed using the Post Traumatic Growth Inventory (PTGI)\n\nMinimum: 0 Maximum: 105 Higher score= better (positive) post traumatic growth transformation"}, {'measure': 'Waist to hip ratio (body composition)', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using waist to hip ratio (WHR) measure.\n\nMinimum WHR: none Maximum WHR: none Higher score WHR= worse body composition'}, {'measure': 'Anxiety', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using the Spielberger State Trait Anxiety Inventory (STAI)\n\nMinimum: 20 Maximum: 80 Higher score= worse anxiety'}, {'measure': 'Fatigue', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire\n\nMinimum: 0 Maximum: 52 Higher score=worse fatigue'}, {'measure': 'Stress', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using the Perceived Stress Scale (PSS)\n\nMinimum: 0 Maximum: 56 Higher score=worse perceived stress'}, {'measure': 'Shoulder Mobility', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Changes in shoulder mobility\n\nMinimum: 150 degrees (18-50 years); 130 degrees (over 50 years) Maximum: none Higher score= better mobility'}, {'measure': 'Self-Esteem', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Changes in level of self-esteem assessed using Rosenberg Self-Esteem (RSE) scale\n\nMinimum: 10 Maximum: 40 Higher score= better self-esteem'}, {'measure': 'Sleep', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Changes in sleep patterns assessed using the insomnia severity index (ISI)\n\nMinimum: 0 Maximum: 28 Higher score= worse insomnia'}, {'measure': 'Motivation', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Questions based on the theory of planned behaviour\n\nMinimum: 7 Maximum: 35 Higher score= better motivation'}, {'measure': 'Cancer specific quality of life', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H\\&N Symptom Index)\n\nMinimum: 0 Maximum: 40 Higher score= worse head and neck cancer symptoms'}, {'measure': 'Cancer Symptom Burden', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using the revised Edmonton Symptom Assessment System (ESAS-r)\n\nMinimum: 0 Maximum: 100 Higher score= worse cancer symptoms'}, {'measure': 'Height', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using standing height without shoes.\n\nMinimum height: none Maximum height: none Taller: not specifically better or worse'}, {'measure': 'Weight', 'timeFrame': 'Changes from baseline to 12 weeks', 'description': 'Assessed using a digital scale without shoes.\n\nMinimum weight: none Maximum weight: none Higher weight: typically worse, but depends on other factors (ie. height, muscle mass, overall health status)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'neck dissection', 'strength training', 'survivors', 'exercise'], 'conditions': ['Cancer of Head and Neck']}, 'referencesModule': {'references': [{'pmid': '37212970', 'type': 'DERIVED', 'citation': "Ntoukas SM, McNeely ML, Seikaly H, O'Connell D, Courneya KS. Feasibility and safety of Heavy Lifting Strength Training in Head and Neck Cancer survivors post-surgical neck dissection (the LIFTING trial). Support Care Cancer. 2023 May 22;31(6):348. doi: 10.1007/s00520-023-07815-2."}]}, 'descriptionModule': {'briefSummary': 'The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.', 'detailedDescription': 'RATIONALE Despite improvements in treatments, HNCS still endure numerous acute and chronic side effects. Strength training has been shown to manage some of these side effects but most interventions have involved light-to-moderate resistance training programs. HLST may produce better outcomes but it is unknown if such a weight training program is feasible and safe for HNCS.\n\nOBJECTIVE The primary aim of this proposed study is to examine the feasibility and safety of a HLST program in HNCS at least 1 year post-surgical neck dissection.\n\nMETHODS This single arm feasibility study will recruit 15-20 HNCS to complete the HLST program 2 times per week. The primary feasibility outcomes will include the eligibility rate (with reasons for ineligibility), recruitment rate (with reasons for refusal), 1 repetition maximum testing rate (with reasons for not completing the test), program adherence (including attendance, dose modifications, and progression), and follow-up assessment rate (with reasons for drop out). The primary efficacy outcome will be strength gains from baseline. Secondary efficacy outcomes will include physical functioning, quality of life, fear of cancer recurrence, pain, body composition, anxiety, fatigue, stress, shoulder mobility, self-esteem, sleep, and motivation to engage in a HLST program.\n\nSIGNIFICANCE Weight training is an effective intervention in HNCS but the optimal weight training prescription is unknown. If heavy weight training is deemed safe and feasible in HNCS, it can be compared to light-to-moderate load weight training to determine if it is a better prescription for improving outcomes that are important to HNCS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previously diagnosed with any subtype and stage of head and neck cancer\n* at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve\n* adults ages 18 and older\n* no unmanaged medical conditions, alcohol, and drug abuse\n* approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist\n* ability to understand and communicate in English\n\nExclusion Criteria:\n\n* having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise'}, 'identificationModule': {'nctId': 'NCT04554667', 'acronym': 'LIFTING', 'briefTitle': 'Heavy Lifting Strength Training in Head and Neck Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Feasibility and Safety of Heavy Lifting Strength Training in Head and Neck Cancer Survivors Post-Surgical Neck Dissection', 'orgStudyIdInfo': {'id': '20-0169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Intervention', 'description': 'Single exercise arm', 'interventionNames': ['Behavioral: Exercise Intervention']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Heavy Lifting Strength Training', 'armGroupLabels': ['Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2H9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Kerry S Courneya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}