University of Alberta
Edmonton, Alberta, Canada
Location status: Recruiting
NCT Number: NCT06289049
Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS.
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Request Info18 year and older
All sexes
Interventional
Phase 2
Edmonton, Alberta, Canada
Location status: Recruiting
Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS.
The primary aim of the proposed study is to further establish the feasibility of HLST in HNCS which will be based on the eligibility rate, recruitment rate, one-repetition max (3RM) testing rate, HLST program adherence, and follow-up assessment rate. A secondary aim is to provide preliminary evidence of the effects of a HLST program compared to usual care (UC) in HNCS. The primary efficacy outcome will be upper and lower muscular strength assessed by reliable 3-repetition maximum (3RM) tests on the chest press and leg press machines. Secondary efficacy outcomes include physical function, handgrip strength, body composition, QoL, fear of cancer recurrence, symptom burden, pain, anxiety, fatigue, stress, self-esteem, shoulder mobility, sleep, malnutrition status, and swallowing abilities.
This single-centre, two-armed, randomized controlled trial will recruit 60 HNCS ≥1-year posttreatment, and randomly assign them to the HLST group or UC group. For the HLST group, the 12-week exercise intervention will include supervised training 2 days per week. The HLST group will progress to lifting low repetitions of heavy loads at 80-90% of one repetition maximum (1RM), whereas the UC group will not receive any exercise prescription or instruction during the 12-week intervention, but will be offered a 4-week introduction to HLST program and/or referred to a community-based program after the postintervention assessments are complete. Assessments for both groups will occur at baseline and postintervention and include reliable 3RM strength tests, bioelectrical impedance analysis (BIA), Senior's Fitness Test, and validated QoL questionnaires.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three primary exercises will be included in the exercise sessions for participants randomized to this group: barbell back squat, bench press, and dead lift
The weight will be progressively increased overtime based on participants' perceived exertion and repetitions in reserve. Number of repetitions performed for each exercise will begin at 10 repetitions in weeks 1-2, with gradual progression to lifting heavier loads of 3-5 sets of 1-5 repetitions between weeks 6-12.
Other names: Exercise Group
Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Recruitment range: 40 to 60 participants; Higher=better and more available data
Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Adherence rate: 0 to 100 percent of exercise sessions; Higher=better
Time frame: Baseline and postintervention (12 weeks)
3 repetition maximum testing rate: 0 to 100 percent; Higher=better
Time frame: Postintervention (12 weeks)
Followup assessment rate: 0 to 100 percent; Higher=better
Time frame: Baseline, postintervention (12 weeks), and monitored throughout 12 week study period
Adverse events: minimum: no adverse events, maximum: no maximum. Higher=worse
Time frame: Baseline and Postintervention (12 weeks)
Assessed via 3 repetition maximum tests on the chest press and leg press machines
Minimum: 0 kilograms, Maximum: none. Higher score=better strength
Time frame: Baseline and Postintervention (12 weeks)
Assessed via cancer specific European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Minimum: 0 points, Maximum: 100 points. Higher score=better quality of life
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the Fear of Cancer Recurrence Inventory - Short Form
Minimum: 0 points, Maximum: 36 points. Higher score=worse fear of cancer recurrence
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the revised Edmonton Symptom Assessment System
Minimum: 0 points, Maximum: 100 points. Higher score=worse cancer symptoms
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the Perceived Stress Scale
Minimum: 0 points, Maximum: 56 points. Higher score=worse perceived stress
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the Rosenberg Self-Esteem Scale
Minimum: 10 points, Maximum: 40 points. Higher score=better self-esteem
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the Insomnia Severity Index
Minimum: 0 points, Maximum: 28 points. Higher score=worse insomnia
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the Patient Generated Subjective Global Assessment with reference to the Global Leadership Initiative on Malnutrition
Minimum: 0 points, Maximum: 36 points. Higher score=worse, high risk of malnutrition
0-1 points: no intervention required at this time. Re-assessment on routine and regular basis during treatment.
2-3 points: patient & family education by dietitian, nurse, or other clinician with pharmacologic intervention as indicated by symptom survey and lab values as appropriate
4-8 points: requires intervention by dietitian, in conjunction with nurse or physician as indicated by symptoms
≥ 9 points: indicates a critical need for improved symptom management and/or nutrient intervention options
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the MD Anderson Dysphagia Inventory
Minimum: 20 points, Maximum: 100 points. Higher score=better swallowing ability
Time frame: Baseline and Postintervention (12 weeks)
Assessed via seated active flexion and abduction using a goniometer
Minimum: 150 degrees (18-50 years); 130 degrees (over 50 years), Maximum: none Higher score=better shoulder mobility
Time frame: Baseline and Postintervention (12 weeks)
Assessed via bioelectrical impedance analysis (InBody 770)
Minimum: none, Maximum: none. Higher score=variable Higher fat free mass score=better Higher fat mass score=worse
Time frame: Baseline and Postintervention (12 weeks)
Assessed via held held dynamometer
Minimum: 0 kilograms, Maximum: none. Higher score=better hand grip strength
Time frame: Baseline and Postintervention (12 weeks)
Assessed via the six minute walk test
Minimum: 0 metres, Maximum: none. Higher score=better physical function
Contact information is provided by the study sponsor or research team.
University of Alberta
Other
Feasibility and Preliminary Efficacy of Heavy Lifting Strength Training Versus Usual Care in Head and Neck Cancer Survivors: A Randomized Controlled Trial
Acronym: LIFTING2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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